Market Insight

Tandem Diabetes Care has received CE mark expansion in Europe for its Control-IQ+ automated insulin delivery (AID) systems, enabling use in adults with type 2 diabetes and people with type 1 diabetes during pregnancy.
The approval covers the company’s t:slim X2 and Tandem Mobi insulin pumps, which au

Carvolix has raised an additional €10 million tranche, bringing total funding under its €30 million financing programme to €20 million. The new capital reflects continued support from existing strategic shareholders and is intended to support both commercialization and clinical development of its AI

Tissium has raised $68 million (€60 million) through a combination of a $34 million Series D2 financing and a $34 million financing facility from the European Investment Bank (EIB).
The funding comes as the company advances the commercialization of Coaptium Connect with Tissium Light, its FDA-authori

Valgen Medtech has received CE mark approval for its DragonFly transcatheter mitral valve repair system for the treatment of functional mitral regurgitation (FMR), expanding on the device’s approval for degenerative mitral regurgitation (DMR) granted in April 2025.
The milestone makes DragonFly the f

AorticLab has received an expanded CE mark for its FLOWer embolic protection device, allowing broader use in transcatheter cardiovascular procedures beyond TAVI.
The device is designed to be deployed in the aortic arch, where it captures debris during procedures to reduce the risk of embolic events a

LEM Surgical has received a new FDA 510(k) clearance for its Dynamis robotic surgical system, expanding the platform’s capabilities in spine surgery and marking its second FDA clearance in 2026.
The approval adds individual vertebra tracking, a robotic bi-manual stabilization workflow, and support fo

CroíValve has expanded its Series B financing to $36 million, adding $20 million in new funding to the $16 million raised in 2024. The company also secured $7 million in grant funding from the European Innovation Council (EIC) and Ireland’s Disruptive Technologies Innovation Fund (DTIF).
The funding

HistoSonics has closed a new financing round to support the continued growth of its Edison histotripsy platform, bringing the company’s valuation to $3.75 billion.
The round included participation from Reed Jobs, Yosemite, and strategic investors. The funds will support commercial expansion, clinical

Masimo has received FDA clearance for an AI-enabled opioid-induced respiratory depression (OIRD) detection capability designed for its Radius VSM wearable continuous monitoring system.
The technology uses Masimo’s smartSET pulse oximetry platform and advanced pattern recognition to analyze continuous