Market Insight

Cardiawave has announced the first patients treated in Europe with its Valvosoft platform, following the system’s CE mark approval for severe symptomatic aortic stenosis (sSAS).
Valvosoft uses non-invasive focused ultrasound therapy to restore movement in narrowed aortic valve leaflets. The technolog

SurGenTec has received FDA clearance for its ION-L lumbar facet fixation system for patients with degenerative disc disease (DDD) affecting the L3 to S1 levels who have not responded to conservative treatment.
Designed for posterior lumbar procedures, ION-L aims to provide a less invasive alternative

UNEEG Medical has received FDA 510(k) clearance for its UNEEG EpiSight System, a minimally invasive implant designed for continuous, long-term EEG monitoring in patients with epilepsy.
The system uses a small subcutaneous implant placed beneath the skin to record brain activity over extended periods

Raydiant Oximetry has completed enrollment and data collection for the first 15 patients in its FDA-approved IDE pilot study at LSU Health Shreveport, advancing development of its fetal pulse oximetry technology.
The study evaluates Raydiant’s investigational transvaginal fetal oxygen sensor, designe

Spectrum Vascular has acquired Piccolo Medical, a developer of FDA-cleared catheter guidance technology, in a move aimed at strengthening its vascular access offerings.
The acquisition centers on Piccolo’s PM2+ system, which uses proprietary blood flow sensing to enable real-time catheter tip placeme

Nyxoah has secured $110 million in new capital to support the U.S. commercial expansion of its Genio implantable therapy for obstructive sleep apnea (OSA).
The financing includes $95 million in equity funding and an expected $15 million second tranche from the European Investment Bank loan. The funds

CeQur has raised $100 million in Series E financing to support the expansion of its Simplicity wearable mealtime insulin patch, a device designed to make insulin delivery easier for people with diabetes. The Switzerland-based company developed Simplicity as a wearable alternative to traditional insu

GT Medical Technologies has closed an oversubscribed $100 million Series E financing to support the growth of its GammaTile radiation therapy device, designed for patients undergoing brain tumor removal surgery.
Led by Viking Global Investors, the round included participation from existing investors

US company Xtant Medical Holdings has commercially launched the Trivium Shaped allograft, a new addition to its Trivium bone graft range for surgical use.
The product is available through the company’s distribution network in pre-shaped forms to support handling, preparation, and positioning across v