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Editors’ Choice: Q1 2024 in MedTech

2024 has kicked off on a high note for the MedTech industry, witnessing a surge of groundbreaking advancements. As we step into April, it’s a fitting time to reflect on the pivotal moments encompassing funding, innovations, clinical trials, and regulatory approvals in our quarterly editors’ recap. 

Biobot Surgical has recently concluded a successful Series B funding round, securing £18 million to propel its innovative surgical robot, the Mona Lisa, into the next phase of development. Spearheaded by healthcare entrepreneur Tony Tan and supported by existing shareholder Zig Ventures, the funding aims to expedite Biobot’s global expansion and enhance its commercial presence. CEO Albert Lee hailed the round’s closure as a significant milestone in Biobot’s mission to revolutionise transperineal biopsy and treatment methodologies. 

In a parallel vein, CerraCap Ventures, a prominent player in healthcare innovation investment, has chosen to back Acorai, an innovative company in cardiovascular health technology. This strategic investment is set to catalyse the advancement and deployment of Acorai’s groundbreaking Acorai Heart Monitor (AHM), designed to address critical challenges in heart failure management. AHM’s precision in measuring intracardiac pressures non-invasively marks a transformative leap in heart failure monitoring, empowering healthcare providers with accurate data crucial for effective patient management. 

Pixee Medical, renowned for its augmented reality navigation technologies for orthopaedic surgery, has embarked on a significant expansion journey following a €17,5 million capital-raising effort. Led by key investors including Relyens Innovation Santé, UI Investissement, Innovacom, Angelor, and Bpifrance, this transaction positions Pixee Medical to accelerate its growth in the United States and roll out its next generation of innovative products. This infusion of funds underscores Pixee Medical’s commitment to pioneering advancements that optimise surgical outcomes and enhance patient care. 

Regulatory Approvals 

Just a month ago, Pulse Biosciences, Inc. achieved a major milestone with FDA 510(k) approval for its CellFX nsPFA system, designed for soft tissue ablation in percutaneous and intraoperative surgical procedures. This clearance represents a significant advancement in the realm of non-thermal cellular ablation, empowering clinicians with a precise tool to target cells without affecting adjacent noncellular tissue. 

Meanwhile, EDAP TMS garnered FDA breakthrough device designation for its Focal One platform, aimed at treating deep infiltrating endometriosis (DIE). Building upon the FDA’s previous approval of the Focal One HIFU system for prostatic tissue ablation, this designation underscores Focal One’s potential as a non-invasive, robotic ablative solution for addressing endometriosis, a condition affecting millions of women worldwide. 

In a similar context, back in February neuro42 received FDA 510(k) clearance for its portable diagnostic MRI scanner, a groundbreaking development poised to transform point-of-care imaging for patients with critical neurological conditions. By eliminating the need for patient transportation to imaging suites, neuro42’s MRI System promises timely diagnosis and improved treatment outcomes, representing a significant leap forward in neurological care delivery. 

Clinical Trials 

MediView XR unveiled promising results from a trial evaluating its XR90 surgical visualisation and navigation system, showcasing its clinical precision in guiding procedures with unparalleled accuracy. Leveraging 3D X-ray vision, the XR90 system equips physicians with comprehensive insights into a patient’s internal anatomy, empowering them to conduct procedures with heightened precision and efficacy. 

Cognito Therapeutics initiated a biomarker substudy within its HOPE pivotal trial, focusing on evaluating the efficacy of its GammaSense Stimulation system in Alzheimer’s disease patients. This substudy, alongside the main trial assessing sensory stimulation therapy, aims to elucidate the therapeutic potential of Cognito’s innovative approach in preserving cognitive function and mitigating disease progression. 

Sensome commenced a feasibility clinical study utilising its Clotild® Smart Guidewire in peripheral artery disease (PAD) patients, marking a significant step forward in advancing vascular disease management. Through real-time detection of blood vessel blockages, the Clotild® sensor holds promise in enhancing diagnostic accuracy and optimising treatment strategies for patients with PAD. 


CMR Surgical launched its Versius system in Sweden, marking a significant milestone as Norra Älvsborgs Sjukhus becomes the first hospital in the Nordics to conduct robotic-assisted surgeries with Versius. This multispecialty robotic surgery programme underscores Versius’s versatility and potential to expand access to minimal access surgery across various medical specialties. 

Nanoflex Robotics introduced its remote-ready robotics system for neurovascular procedures in the U.S., offering physicians unprecedented control and precision in complex vascular interventions. By leveraging magnetic, micro-robotic technology, Nanoflex Robotics aims to revolutionise stroke care delivery, minimising treatment delays and maximising patient outcomes.  
More recently, Affluent Medical achieved a groundbreaking milestone with the successful first-in-human implant of its minimally invasive urinary incontinence treatment device, Artus. This milestone underscores Affluent Medical’s commitment to addressing unmet clinical needs and improving patient quality of life through innovative medical solutions. 

The convergence of technological innovation, regulatory support, and clinical research underscores the MedTech sector’s commitment to driving positive change in healthcare delivery. As we move forward, continued collaboration between industry stakeholders, healthcare providers, and regulatory agencies will be vital in navigating the complexities of bringing new technologies to market while ensuring patient safety and efficacy.  
These advancements reflect a concerted effort by companies and investors to push the boundaries of medical technology, with a clear focus on enhancing patient care and outcomes. With such promising developments in the first quarter of 2024, we eagerly anticipate what the rest of the year will bring. 

Guided Solutions is the Executive Search partner of choice to the global Medical Device industry. We connect visionary companies with our continually expanding network of 140,000+ medtech professionals, fulfilling the potential of technology and talent.   

Whether you have a priority hire, which requires immediate attention, or you are exploring the idea of adding to your team and would like some advice, contact us today and we will guide you through the hiring journey. 

Editors’ Choice: Q3 2023 in MedTech

The MedTech world experienced a wealth of pioneering breakthroughs during the third quarter of 2023. With the start of November, let’s take a moment to review the key highlights across funding, innovations, clinical trials, mergers, acquisitions, and regulatory approvals in our quarterly editors’ recap.

In an effort to provide reliable in vitro diagnostics, Siemens Healthineers unveiled the Atellica CI Analyzer, offering improved turnaround time predictability, advanced reporting functionality, and stringent safety measures. The Atellica CI Analyzer makes it possible for both standalone labs and satellite labs of wider health networks to have the same reagents, consumables, and intelligent software as the company’s flagship Atellica Solution—now condensed into a 1.9 square meters footprint ideal for smaller laboratories.

Meanwhile, researchers from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, designed a device that can help test treatments in patients with gliomas, a type of tumor that originates in the brain or spinal cord. The device, which is designed to be used during standard-of-care surgery, provides unprecedented insight into the effects of drugs on glioma tumors and caused no adverse effects on patients in a phase 1 clinical trial.  

Regulatory Approvals
The third quarter of the year got off to a strong start as MediView XR received FDA 510(k) clearance for its augmented reality surgical navigation platform, XR90, which allows physicians to view a patient’s anatomical structures in 3D for preoperative and intraoperative use. 

The Ohio-based MedTech company’s XR90 combines CT imaging with ultrasound, allowing 3D holographic images to be displayed anatomically underneath the patient’s skin, enabling providers to perform minimally invasive procedures, such as tumor ablations and biopsies. 

More recently, Tyber Medical achieved regulatory approval for its implantable K-Wires and Steinmann Pins from both the US Food and Drug Administration (FDA) and the European Union Medical Device Regulation (EU MDR). Available in sterile and non-sterile options, the approved K-Wires and Steinmann Pins are offered in several configurations, including combinations of trocar tip, diamond tip, fluted tip, partial thread, full thread, ball end and flat end.

Tyber Medical CEO Jeff Tyber said: “Our focus has always been on developing products that are innovative, efficient and deliver unparalleled performance. Receiving the FDA and MDR clearance for these platforms is a testament to our rigorous pursuit of advancing patient care while helping our customers expand their brand.”

Two more regulatory approvals that took center stage during Q3:
Johnson & Johnson’s Atrial Fibrillation Ablation Devices without Fluoroscopy: The US Food and Drug Administration (FDA) granted its approval to Johnson & Johnson’s catheter-based atrial fibrillation ablation devices, and notably, these devices can now be used without the need for fluoroscopy. This milestone represents a significant enhancement in cardiac care, promising a safer environment for both patients and medical practitioners during these procedures. 

DermaSensor’s positive results for skin cancer detection device across multiple skin tones: DermaSensor’s handheld elastic scattering spectroscopy (ESS) device has made a remarkable impact by demonstrating a high level of sensitivity in the detection of all types of skin cancer, achieving an impressive 96% accuracy rate. Equally remarkable is its consistent performance across various Fitzpatrick skin type subgroups. This regulatory approval signifies a groundbreaking development in the realm of dermatology and skin cancer detection, offering the potential for improved diagnostic accuracy and accessibility for a broader range of patients.

Clinical Trials
Just a month ago, Medidata unveiled the Medidata Diversity Program, a forward-thinking initiative focused on promoting diversity, equity, and inclusion within clinical trials. The program seamlessly integrates the expertise from Medidata’s AI and Patient Cloud portfolios, culminating in a comprehensive strategy tailored to meet regulatory requirements and boost inclusivity within clinical trials.

Zooming out to the broader landscape of clinical trials and medical advancements, July marked a significant milestone in Alzheimer’s Disease research. Cognito Therapeutics made significant progress with recent MRI data showcasing lobe-specific changes in white matter volume and myelination in Alzheimer’s Disease patients.

The company presented new imaging data at the Alzheimer’s Association International Conference 2023 from the Phase 2 OVERTURE study, that reported its proprietary gamma sensory stimulation therapy reduced the decline in white matter/grey matter (WM/GM) contrast in the entorhinal region. The entorhinal region of the brain is of particular interest in the early stages of AD, and early intervention with Cognito’s therapy may result in enhanced tissue preservation and reduced neurological damage. 

CMR Surgical marked a significant milestone, completing over 15,000 global surgical procedures using their Versius® system. To fuel their expansion, they secured $165 million in funding.

CMR was established in 2014 with a mission to transform lives by making minimal access surgery (MAS) more accessible and affordable with Versius, a small, modular, and versatile surgical robotic system. The surgical cases span more than 130 complex and benign procedure types including colectomies, hernia repairs, hysterectomies, sacrocolpopexies, and lobectomies across seven surgical specialties. The funding round of $165 million (£133m), which was increased from the initial base size due to strong internal demand, was led by all of its major existing investors, including Ally Bridge Group, Cambridge Innovation Capital, Escala Capital, LGT, Lightrock, RPMI Railpen, SoftBank Vision Fund 2, Tencent and Watrium.

In a similar context, SpineX managed to secure essential funding for advancing the SCiP device’s pivotal clinical trial aimed at children with cerebral palsy (CP), a childhood movement disorder. This crucial funding comes from the National Institutes of Health, facilitated through the Small Business Innovation Research Awards. 

The data gathered during the trial will play a central role in the company’s pursuit of US Food and Drug Administration (FDA) approval, paving the way for marketing and further development of the device.  

Mergers & Acquisitions
Abbott announced a definitive agreement to acquire Bigfoot Biomedical, a leader in developing smart insulin management systems for people with diabetes. This move aims to further develop connected solutions for making diabetes management more personal and precise. 

Enovis Corp agreed to acquire Italian surgical implant manufacturer LimaCorporate for about 800 million euros ($850 million), including debt. This acquisition will bolster the US company’s reconstructive business and expand its international footprint.

Inogen completes its acquisition of PhysioAssist, a leading provider of innovative medical devices. This strategic move aligns with Inogen’s strategy to diversify its portfolio and expand market opportunities imminently.

The third quarter of 2023 has proven to be a period of groundbreaking advancements and transformative shifts in the MedTech landscape, setting the stage for a future where healthcare is safer, more accessible, and patient-centric. These developments reflect the relentless pursuit of innovation and the commitment to improving patient care on a global scale. 

Guided Solutions is the Executive Search partner of choice to the global Medical Device industry. We connect visionary companies with our continually expanding network of 120,000+ medtech professionals, fulfilling the potential of technology and talent.  

Whether you have a priority hire, which requires immediate attention, or you are exploring the idea of adding to your team and would like some advice, contact us today and we will guide you through the hiring journey. 

Five Reasons to Use a MedTech Recruiter to Address your Hiring Needs

Are you still wondering why companies working in MedTech use specialised recruiter to help them fill out roles? In our latest blog, we present you with 5 reasons why we believe partnering with a specialised recruiter can help your business needs and solve your hiring challenges.

  1. Benefit from their specialised talent pool and skills to find new candidates.

Recruitment companies in MedTech spent years building their databases of qualified candidates in the industry. They also take time to connect with potential candidates, meaning they can quickly and efficiently select candidates who possess the specific skills and experience needed for your company. This access to a specialized talent pool can save your organization valuable time and effort in sourcing qualified candidates. At Guided Solutions, we have placed over 9000 candidates in 40 countries across 500 companies, which has helped us build the necessary connections and grow our network.

  1. Tap into their industry knowledge.

To be successful in the industry, specialised MedTech recruiters invest time in developing a deep understanding of the sector which evolves rapidly. This helps them comprehend challenges and the specific skills required for various roles. They can effectively assess candidates’ qualifications, industry knowledge, and regulatory understanding to ensure the right fit for your company. Their expertise can streamline the hiring process and increase the chances of finding high-quality candidates. At Guided Solutions, this process is led by one of our company directors who possess over 20 years of experience, which makes the process even more efficient.

  1. Save you time and money

The hiring process can take time and valuable resources from your team and company. When you engage a recruiter, you are saving your company the difficulty of sourcing, screening, and shortlisting candidates, allowing your internal team to focus on core business activities. Specialised Medtech recruiters can also streamline the hiring timeline, reducing the time-to-fill positions. These time and cost savings can be especially beneficial in a competitive industry like medical devices, where talent acquisition can be challenging. This is why at Guided Solutions, we work hard as a team to provide you with the best candidate without the burden of internal targets or competition.

  1. Ensure confidentiality and discretion.

Certain roles including senior-level ones require maintaining confidentiality. Acting as a neutral intermediary, recruiters can ensure that sensitive information is secured and shared only with qualified candidates that have been pre-screened. This is crucial for maintaining your reputation and getting the crème-de-la-crème of the market. At Guided Solutions, we ask candidates to fill in a non-disclosure agreement for confidential roles to maintain the integrity of the hiring manager and company involved.

  1. Benefit from their scalability and flexibility

The fast-paced MedTech industry is known for its fast pace and fluctuating talent needs due to the company’s product development cycles, market demand, or expansion plans. Recruiters can provide scalability and flexibility to match your hiring requirements. Whether you need to quickly ramp up a team for a new product launch or find specialized talent for a short-term project, recruiters can adapt their search and selection process to meet your changing needs. At Guided Solutions, we tailor our search and selection process to your hiring needs, considering all success indicators against the realities and opportunities presented by the talent market.

It is a fact using a recruiting partner is advantageous in many ways. However, it is important to choose the right one, which can demonstrate experience but also an understanding of your hiring needs and culture. Get in touch with Guided Solutions today so we can chat about your hiring challenges.

If you are interested in learning more about Guided Solutions and how we can help you with your hiring needs, please fill in the form using the link.

Selling Medical Devices into the Operating Theatre

Theatre sales is a specialist field within medical devices sales. Employees working in this area can expect to handle sales of medical devices to operating theatre staff, A&E, anaesthesia and critical care departments. This means that sellers will be required to have a great deal of knowledge covering these fields, and to be able to demonstrate the equipment they are selling to potential customers.

Sales made in theatre departments can range from low-end, inexpensive but necessary equipment such as theatre gowns, disposable gloves and swabs, and essential items such as soaps and products used to clean wounds to complex products such as prosthetics or endoscopy equipment, orthopaedic implants and cardiac or vascular devices. These are typically sold directly into theatre during a surgical procedure. The sales rep will stand by the surgeon’s side, fully scrubbed up, answering technical queries and ensuring that the product is being properly used, essentially becoming a vital member of the clinical theatre team. Demonstrating the workings of each device to senior surgeons and consultants and showing them how the devices can be managed are also key responsibilities of the role.

Applying for a Theatre Sales role

If you want to develop a career in medical devices theatre sales, then you should be aware that this area is very competitive, and there are many medical sales reps applying for these positions. In order to succeed, you must have specialist knowledge of the operating theatre, background in sales, as well as relevant qualifications in medical or medical technology areas. You will also need to have a good idea of competitor devices, and how your company’s products differ. Many companies will also look for experienced sales reps who have been able to introduce new customers to their company, or who have made significant sales.

What can I expect?

Starting a role as a theatre sales representative often involves extended driving between locations. Many companies expect their sales reps to be able to cover large areas. Most reps should also be able to manage sales figures, including demonstrating planning skills, and working with the company to work out the best way to maximise sales. You can also expect to be set a series of targets by the company, including sales to particular companies, and sales of more expensive ites.

Theatre sales reps can usually expect to earn between £30,000 and £35,000 per annum, with bonuses in the area of £5,000. This role is generally more specialised than being a Product or Brand manager, but it pays similarly. Sales reps looking to advance their career should consider this a step towards developing a broader knowledge base, or developing a specialism which can then be used when becoming a senior manager.


Guided Solutions is Europe’s leading medtech recruitment consultancy. Join our 21,000+ LinkedIn community and stay up to date with latest international jobs and medical device industry updates.

The Woundcare Sales Representative

Woundcare sales representatives offer products that close and heal wounds, and work with both primary and secondary healthcare staff. This means that the role involves travelling to both hospitals and GP surgeries. Woundcare is a field where new medical technology is constantly innovating, and a growing area of sales for many companies, so sales representatives are in demand. Being able to see how these devices heal patients, and then explain them to medical professionals, is the most rewarding part of this job.

Many companies operating a Woundcare or wound management division will require sales reps who already have experience in medical sales, and often medical qualification, as they will have to establish close links with clinical professionals, including providing demonstrations and training for devices. Becoming a woundcare sales rep can mean taking on new skills, including organisation and planning which will help you manage your work schedule, and keep up to date with demonstrations of samples.

Applying for a Woundcare Sales role

Most companies will ask for experience with medical devices, although some will also consider pharmaceutical experience. Having a BSc in nursing, or equivalent experience in a clinical setting, will help get the qualifications that you need.

Experience in a field setting is often viewed as essential for woundcare sales representatives, since the field is constantly evolving and hospital staff need training on new devices. Having the confidence, knowledge and communications skills that come with previous sales experience benefits everyone.

What can I expect?

Woundcare sales representative salaries start at around £30,000 and increase through bonuses and commission, so there may be an additional 20-30% above the basic pay rate for those prepared to work hard. Transporting medical samples between hospitals is a big responsibility that requires strict organisation skills and the ability to work out how many types of each sample you will need on a working day. These skills can be learnt before starting the role, or developed on the go.

The job involves travelling broad distances, and talking to various hospital and surgery staff, including people with limited knowledge of the company’s devices as well as specialists seeking improvements in their current models. All these types of customers can present different challenges to the woundcare rep. Being able to communicate the benefits of your product will ensure that professional staff have a clear understanding of how it can enhance their current medical procedures.

Since its inception in 2000 Guided Solutions has placed more than 8500 candidates in over 37 countries.

We identify and recruit medical device specialists at all seniority levels, enabling our clients to connect with associate through to board-level talent.

Visit our website to register and find out more.

The Medical Devices Sales Industry

Medical devices are essential part of modern medical industry. From the very first implant of a pacemaker, they have become an indispensable part of hospital treatments. There is a vast range of devices out there, from those used to detect and treat diseases, to those used in the patient’s own hope to control illness and reduce the cost of healthcare, to latest developments in AI, digital health, blockchain and healthcare IT. As technology keeps accelerating, we rely even more upon these devices, and sales will keep flourishing. The medtech market size is projected to expand at a CAGR of 5.4% between 2019 and 2025. In 2018, the market accounted for a value of US$425.5Bn and is likely to reach US$612.7Bn by 2025.

The medical device sales industry covers all varieties of devices, from basic hospital equipment such as face masks and syringes to instruments for monitoring patients, and high-end technology such as laboratory equipment and scanning and treatment machines. Devices are classified into various groups depending on their clinical application. For example. there are in-vitro kits including diagnostics, prosthetics and artificial limbs and joints, such as those used for hip replacements, anaesthesia and endoscopy, to name but a few.

The medical device sales industry is constantly changing and expanding in response to the development of new technology as well as to external challenges affecting human health – most recently the COVID-19 pandemic. This means that the industry is constantly looking for people who have the knowledge to understand new devices or changes to existing devices. The global medical device industry is mostly dominated by large companies from North America, while market leaders in Europe are Germany, the UK and Switzerland. The industry is hypercompetitive, and startups and small companies have to have the skills and knowledge to compete against large multinationals.

One of the ways in which startups and SMEs companies can overcome their small size is by focusing upon the value of their service or product. As the driving forces behind innovations improving current technology, these firms can add value to their sales drive by promising better care, reduced waiting times and increased efficiency, ultimately adding economic value to their product or service.

Adding value to medical devices means having in-depth knowledge of not only the technology itself, but how it can be embedded into the modern realities of healthcare systems, hospitals or people’s everyday lives. Anyone working in this industry therefore needs to have the ability to develop strong relationships with key stakeholders, decision-makers, and patients.

Since its inception in 2000 Guided Solutions has placed more than 8500 candidates in over 37 countries.

We identify and recruit medical device specialists at all seniority levels, enabling our clients to connect with associate through to board-level talent.

Visit our website to register and find out more.

Editors’ Choice: 2020 in Medtech

2020 will be remembered as the year marked by COVID-19. The profound impact of the pandemic can be seen in every aspect of our existence, from people’s everyday lives to businesses, economy, global politics and international mobility.

The medical device industry wasn’t spared either – slowdown in investments, halt in clinical trials, and shifting to the work-from-home reality of doing business marked the past 12 months and could well be here to stay.

Despite the tough challenges and its key role at the forefront of the battle against the outbreak, medtech kept growing. So let’s take a look at the most popular events that marked 2020 across innovation, clinical trials, regulatory, M&A and funding according to the Guided Solutions LinkedIn community in our traditional end-of-year recap:


New robot does superior job sampling blood

Robots taking blood samples, benefiting patients and healthcare workers alike…does this sound like the future? Not anymore! A Rutgers-led team created a blood-sampling robot that performs just as well or better than humans, according to the first human patient clinical trial.

The automated blood drawing and testing device has overall success rate of 87% across the total 31 trial participants, and 97% for the 25 whose veins were easy to access. It provides quick results and would allow healthcare professionals to spend more time treating patients in hospitals and other settings.

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True Digital Surgery and Aesculap AG launch the Aesculap Aeos Robotic Digital

Amidst the challenges of the COVID-19 pandemic, TDS and AESCULAP launched the innovative Aesculap Aeos Robotic Digital Microscope to improve safety and efficiency during surgeries, as the heads-up display can be viewed simultaneously by all healthcare workers in the operating room while wearing PPE.

The innovative Image Modes feature delivers augmentation without the need for an overlay, including 3D details with outstanding depth-of-field, fluorescence backlighting and a 10x optical zoom that delivers full resolution regardless of magnification level. As an exclusively digital microscope platform, it can be customized with simple software updates.

“We are proud to bring the fully-digital Aesculap Aeos Robotic Digital Microscope to market, with breakthrough technology that we like to say can ‘see beyond the tissue’ and provide a solution to the limitations of conventional surgical microscopes,” said Aidan Foley, Chairman and CEO of True Digital Surgery.

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Olympus launches new AI platform for endoscopy system

By designing and delivering advanced medical technologies and solutions for medical and surgical procedures, Olympus aims to improve the health and quality of life of patients. Its latest endoscopy system, EVIS X1 improves image detection, characterisation, staging, and treatment. With the newly introduced endoscopy CAD (computer-aided detection and diagnosis) platform ENDO-AID, Olympus has enhanced the capabilities of EVIS X1 through AI technology. The ENDO-AID platform includes the endoscopy application ENDO-AID CADe for the colon and offers real-time display of automatically detected suspicious lesions.

Frank Drewalowski, Head of Olympus Endoscopic Solutions division said: “We are committed to innovation and driving our research and development with passion. Considering ENDO-AID as a first step, we are planning additional AI-powered applications for image detection and characterisation that will elevate endoscopic imaging to uncharted levels.”

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Regulatory Approvals

US FDA approves Compumedics’ MEG neuroimaging technology enabling insurers to be billed

The Orion LifeSpan Magnetoencephalography single Dewar system is a neuroimaging technique that maps brain activity by recording magnetic fields generated by the brain’s natural electrical currents. The technology allows for a dual-helmet system, with one side optimised for adult MEG recordings and the other for children. Sites using Orion LifeSpan will be able bill insurers for MEG examinations.

“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory,” Compumedics Chairman and CEO Dr David Burton said.

The FDA greenlight for the MEG hardware follows the already approved Orion LifeSpan components including amplifiers, the simultaneous EEG subsystem, and the integrated co-registration, neuroimage processing and source estimation software – CURRY. This paves the way for the technology to be used routinely in clinical settings – primarily for epilepsy and pre-surgical brain function mapping.

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CryoLife secures CE Mark for On-X AAP for aortic root diseases

Headquartered in Georgia, CryoLife manufactures and distributes medical devices, as well as implantable tissues for cardiac and vascular surgical procedures that focus on aortic repair. The On X AAP device is a part of CryoLife’s On-X Heart Valve portfolio that consists of On-X Aortic Valve and ON-X Mitral Valve among other prosthetic heart valves. The approval enabled resumed distribution of the device in the EU.

On-X AAP is intended to treat damaged (or rectify malfunctioning of) native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. Aortic root diseases co-exist in almost as much as 10% of all aortic valve replacements.

CryoLife Chairman, President, and CEO Pat Mackin said: “The absence of the On-X AAP from the market since late 2016 has hindered our ability to compete for certain mechanical valve tenders in the EU. With the receipt of the CE Mark on the AAP, we once again have a complete portfolio of On-X products available in Europe, allowing us to be more competitive and potentially drive market share gains in the mechanical valve market.”

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ECG remote monitoring patch receives CE mark

LifeSignals, has received the CE mark for its ECG remote monitoring patch – a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, healthcare and home settings.

The LifeSignals Patch will be sold as a white-labeled device, marketed in Europe through a network of partnerships from OEMs and telehealth software providers to specialist hospital facilities. The patch is available immediately to interested partners. LifeSignals has also developed a cloud-based Holter Analysis platform, incorporating the use of LifeSignals patches, to facilitate the expansion of clinical remote ECG monitoring services.

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FDA approves Abbott’s Bluetooth connected pacemaker, defibrillator implants

The company’s Gallant line—including an implantable cardioverter defibrillator and a cardiac resynchronization therapy defibrillator—features Bluetooth technology, linking the devices with a personal smartphone app to help monitor patients with potentially life-threatening heart arrhythmias.

After pairing the device with Abbott’s myMerlinPulse software, patients and their clinicians can access data tracking the implants’ performance and event history. Care teams can also monitor patients remotely to identify episodes that may occur without any symptoms.

The MRI-compatible Gallant devices were launched in Europe back in February after Abbott received a CE mark. “The positive impact of remote monitoring has been proven repeatedly and leads to better patient outcomes and reduced burden on the healthcare system,” Abbott’s chief medical officer for its cardiac rhythm business, Avi Fischer, said at that time.

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Mergers & Acquisitions

Medtronic buys new spinal cord tech to boost pain therapies unit

Medtronic acquired Stimgenics, a Bloomington, Illinois-based startup that’s developed a novel spinal cord stimulation waveform Medtronic plans to deliver via its Intellis implantable neurostimulator to treat chronic pain.

The Stimgenics mechanism modulates both neurons and glial cells, the latter playing a greater role in chronic pain than previously understood. In a randomized controlled trial with 250 participants, researchers compared Intellis recipients whose devices had standard programming versus Stimgenics programming. Medtronic presented three-month outcomes from the study at the ​North American Neuromodulation Society (NANS) meeting in late January, and unvailed the latest version of the spinal cord stimulator​.

Spinal cord stimulation thwarts pain signals before they reach the brain through an implanted device that sends electrical pulses to the spinal cord area. Medtronic received FDA approval for its Intellis stimulator in 2017. The addition of Stimgenics’ tech, called differential target multiplexed (DTM) spinal cord stimulation, introduces a new mechanism of action for the device.

Medtronic’s addition to the unit comes amid broad deceleration in growth of the SCS market, where it competes with the likes of Abbott and Boston Scientific.

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ICON acquires MedPass International

ICON plc, a global provider of drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device industries, today announced that it has acquired MedPass International, the leading European medical device CRO, regulatory and reimbursement consultancy, that specialises in medical device development and market access.

This acquisition, concluded in late January, further enhances ICON’s Medical Device and Diagnostic Research Services, through the addition of new regulatory and clinical capabilities in Europe. The integration of MedPass International’s services brings noted expertise in complex class 3 medical devices, interventional cardiology and structural heart devices.

Founded in 1991 and headquartered in Paris, MedPass International is the leading European Medical Device CRO and consultancy. The company has served more than 1,000 medical device companies, from start-ups to multi-nationals, and has contributed to the development of hundreds of innovative devices including a number of breakthrough technologies.

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Medable tops off a strong year with US$91M funding round

Decentralized study company Medable has raised a large $91 million funding round as it continues to ramp up the deals in 2020. The series C is a major jump on its two previous rounds, more than doubling in one round the $45 million previously made in two, and was led by Sapphire Ventures with follow-on investment from existing investors GSR Ventures, PPD and Streamlined Ventures.

This also comes after the firm penned a series of deals with life science contractors including the likes of Datavant, PPD and Covance, as it looked to help CROs navigate choppy pandemic waters with its siteless trial model. There has been a real boon for these types of companies in 2020, as the COVID-19 crisis has ripped through the globe and halted thousands of trials, leaving regulators to recommend using the sort of virtual/siteless model Medable and others, like Science 37, offer.

This saw Medable grow its revenue by 500% this year as more companies signed up for its services, which allows trial teams to combine real-world health records, claims, diagnostic and other sources with their clinical trial data.

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Guided Solutions is the Executive Search partner of choice to the global Medical Device industry. We connect visionary companies with our continually expanding network of 120,000+ medtech professionals, fulfilling the potential of technology and talent. 

Whether you have a priority hire which requires immediate attention, or you are exploring the idea of adding to your team and would like some advice, contact us today and we will guide you through the hiring journey.

Coronavirus 101: The future of work

The coronavirus pandemic has changed the world as we know it. Unemployment has skyrocketed on a global scale, and many businesses across all industries have been struggling to keep moving forward. As millions of people are now working from home, there is a clear shift in attitudes towards remote working. A new way of living is here to stay.

Over the last month, restrictions all over the world have been slowly lifting, but many people fear second waves of infections and there is still no clear indicative when and whether companies will be able to resume their old modus operandi.

Will automation dominate human workforce and become the preferred way of doing things wherever possible? What could we expect the future of work to be after the coronavirus crisis blows over?

Technology replacing people

According to a recent report by CEDEFOP that projects levels of automation penetration in Europe across industries affected by the pandemic, between 20%-25% of all new jobs created by 2030 will likely involve high levels of technologisation. These include low-to-mid-level skilled jobs in manufacturing, hospitality, real estate, wholesale and retail, as well as associate-level scientific or engineering positions that are performed by low- to mid-qualified workforce.

Jobs requiring highly-qualified employees on the other hand are less likely to become automated. These include science and engineering professionals, business and numerical professionals, as well as people with legal, cultural and social occupations.

The workspace

Before the COVID-19 pandemic, corporate headquarters were traditionally seen as a key element in employer branding and positioning. Now that some 60% of people in the US and Europe are working from home and social distancing has become the norm for the foreseeable future, tech-savvy businesses with decentralised premises and agile ways of working and communicating are likely to become more attractive employers while big shiny offices might become a status symbol reserved only for businesses with substantial budget and workforce.

For those choosing to return to office work, face masks are mandatory accessories and office layout has changed: greater distance between desks, dividing panels, constant availability of disinfectants and on-the spot screening for symptoms are very likely to become the norm for years to come.

Economic uncertainty

One thing we remember from the global financial crisis back in 2008 is businesses flattening out middle-management layers within their organisations in an attempt to cut costs and counterbalance economic downturn and growing uncertainty.

Are we seeing this scenario repeat during the COVID-19 outbreak, and what are the pros and cons of reducing management in the context of working remotely?

Within a flat company structure where few managers oversee bigger numbers of direct reports, there is naturally more room for error. If businesses are to navigate this situation successfully, they will have to accelerate their digital transformation journey if they haven’t done so already. A shift from the traditional 9-to-5 office working hours to a schedule characterised by trust, respect and flexibility is key.

Economic crisis accelerates automation. Naturally, companies that have successfully undergone digital transformation will thrive. The introduction of high technology across different industries does not necessarily come at the cost of unemployment and loss of jobs. As remote work and telecommuting are becoming increasingly important factors for employee retention, a global need for increased and improved broadband infrastructure should be addressed by governments.


Since its inception in 2000 Guided Solutions has placed 8500+ candidates in more than 500 medical device companies across 37 countries, and counting.

We identify and recruit medical device specialists at all seniority levels, enabling our clients to connect with associate through to board level talent.

Visit our website to find out how our comprehensive range of search & selection services can help your business reach its potential.

Coronavirus 101: The Impact on Medtech

The coronavirus outbreak has caused unprecedented levels of chaos and disruption around the world. As the global need for protective equipment, intensive care and infection prevention has grown exponentially, the medical device industry has become instrumental in the battle against the virus, while facing tough challenges itself.

Just like any other industry driven by innovation acceleration, medtech has been affected by impeded R&D, disrupted sales, manufacturing and supply chain processes, as well as reduced working hours and workforce.

To top these challenges, the industry is under the additional pressure of delivering effective diagnostic products and ultimately a vaccine that will contain the spread of the disease.

The rate of bringing new products to market has slowed down, and once the pandemic is over, the market itself will likely be different to what it used to be. What are the factors with the biggest impact?

Devices in high demand

All devices that have application in coronavirus-related therapy areas are now in high demand. These include: ICU devices such as ventilators and patient monitors; diagnostic tests and IVD kits; personal protection equipment (PPE) and disposables such as surgical gloves, face masks, hand sanitizers, etc. as well as hospital beds and other products needed for the hospitalisation of large numbers of patients.

In addition to COVID-19-related devices, the pandemic is facilitating the acceleration and adoption of several new technologies, too. For example, 3D printing is being extensively deployed in the mass-production of parts for ventilators and face shields.

Within the domain of telemedicine, video consultations, telepathology and teleradiology are growing in popularity. The digital health vertical generally is getting a good boost, with a variety of health apps, remote monitoring and other e-management solutions that utilise predictive analytics, telemetry, HD cameras, data visualisation and advanced reporting capabilities regardless of location.

Devices in low demand

As the global healthcare infrastructure is fully engaged in the effort to contain the spread of the virus, all non-COVID-19 devices fall into the low extreme of the demand spectrum. These include in particular orthopedic devices and implants involved in so called discretionary or elective surgeries such as joint replacements, as well as many non-urgent dentistry procedures.

Due to the halt on field engineering services at most hospital sites, capital equipment replacement cycles will prolong, whilst purchase and installation of expensive medical technology units such as MRI scanners and the like may get postponed.

New devices for diseases other than the pandemic are not reaching market as planned, which will have negative repercussions on patients and healthcare providers alike. Disruptions in supply chain, especially in Europe, are increasing already existing shortages of medical products. Production halts in China will have repercussions on export and therefore availability of wider varieties of medical devices, including generic products.

EU regulatory changes

Most Notified Bodies and other Quality Commissions have paused onsite inspections and audits until further notice. The EU MDR, which was supposed to come into effect on 26 May 2020 has been postponed by additional 12 months. The other important EU regulation anticipated by the industry, the IVDR, remains to be implemented on 26 May 2021. This means that alongside intense production rates during the crisis, IVD manufacturers are under the additional pressure to prepare for the transition next May.

Due to the extremely high demand, all imported PPE and related devices may skip regular CE marking in European countries. Notified bodies in the UK, Germany and France have temporarily relaxed rules on purchasing and importing of such goods from third country manufacturers under the condition that they have already obtained market approval under alternative regulations (US, Canada, Japan or Australia) and their instructions for use have been localised into the language of the receiving country. This relaxed regulatory climate opens an opportunity, albeit temporary, for companies to capitalise on sales and export of such products.

In addition, EU regulatory bodies have provided open access to technical documentation and standards for the local production of medical devices in high demand. Some manufacturers are also launching open source devices such as face shields to support frontline medical staff.

European companies that produce pandemic-relevant devices are now required to obtain authorisation in order to export outside the EU. However, this rule does not apply to Switzerland, Norway and Lichtenstein.

Clinical trials disruption

The medtech industry relies heavily on healthcare facilities for clinical trials. Most medical devices must undergo clinical trials before being made commercially available, followed by post-market follow-up studies. As a result of the pandemic, all these processes have been delayed or disrupted.

Hospital units typically used for monitoring phase-1 trial patients and volunteers are prioritised for the treatment of COVID-19 patients. Competent authorities and other relevant investigational bodies are now operating remotely, on often limited capacity, with focus on responding to the pandemic.

As a result, medical device manufacturers that need to conduct clinical investigations will have to adjust their timeframes as well as budgets on the go. The larger the company or product line, the higher the chance of product launches being affected, unless the device can be used against the pandemic.

Delayed or postponed studies have short-term implications not just on market access for various innovative, often life-saving devices but also on patients that could benefit from them. In the long run, clinical trial and post-market follow up disruptions may incur further costs for both patients and healthcare providers as well as result in loss of certificates for already established, generic products.


At Guided Solutions we have developed several tools in order to facilitate your hiring process during the pandemic.

If your medical device business requires support and assistance during these dynamic times, we are happy to talk and help you navigate successfully through the challenges ahead.

Coronavirus 101: Managing Stress and Anxiety

Just over a month ago, when the WHO announced that the number of coronavirus cases outside China was officially bigger than inside-China infections, we began to see the implications of COVID-19 for businesses and the global economy.

As of today, there is hardly any company big or small that hasn’t had a significant part of its operations disrupted by the spreading pandemic. So many people all over the world are now working full time from home. With most of us being unaccustomed to this way of life, we are experiencing increased levels of stress which can affect not just focus and productivity but our overall well-being.

It can be overwhelming to spend all of your time in the confined space of your home and watch events that can impact the lives of everyone around you unfold from a distance.

There are however many ways to combat the helplessness and anxiety we all feel in weird times like these. Here are a few suggestions:

Develop a routine

What better opportunity to develop a structured daily routine that being stuck at home? Now that you don’t lose precious time commuting, eating, dating and socialising in the world outside, you can enjoy a much more regular and healthy pattern of life. If you were used to having irregular sleeping, eating or exercising habits before the outbreak, now you have a chance to introduce some balance. Your body and mind will be grateful.

Social isolation? Really?

While it is true that we cannot physically go outside and interact with others, let’s face it, the Internet era we live in makes it practically impossible to experience actual social isolation. It’s never been easier to reach out to people and reconnect with old friends. Tools like social networks and videoconferencing platforms make it possible to stay in touch with everyone we care for without exposing ourselves to the virus outside. Appreciate this opportunity and enjoy the time you get to spend with your closest people, albeit virtually.

Beware of news

All the news we watch about the spread of the virus and its impact on the global economy and people’s everyday lives fuel anxiety that can easily burst into panic. If you are the type of person that tends to overthink or worry too much in general, the pandemic can really turn your life into a nightmare now. While it is important to keep up to date with news about the outbreak, try and limit your exposure to reliable media sources only. There is no need to know what is happening everywhere all the time. Checking once a day is more than enough.

Seek help

If you feel you cannot handle it yourself, it’s ok to seek help from outside. Mental health professionals have had an established online presence long before the outbreak, and it just takes a click to enroll in a virtual therapy session or download various apps for managing stress and anxiety. Not to mention that many providers have now launched special offerings or free subscriptions, like this app which uses clinically proven content to reduce low mood.

Don’t forget it’s OK

Anxiety is a natural human response to the unknown, and the truth is there is still way too much about the virus that we don’t know. Add to that the layers of stress that come with social distancing, loss of jobs, economic disruptions, family issues, etc. and you are now a ticking time bomb!

Don’t forget that you are not alone and you should not beat yourself up about feeling on edge. The most important step towards managing stress is accepting the fact that it is normal to feel this way.


Since its inception in 2000 Guided Solutions has placed more than 8500 candidates in over 37 countries.

We identify and recruit medical device specialists at all seniority levels, enabling our clients to connect with associate through to board-level talent.

Visit our website to register and find out more.