Medline hit with FDA warning letter over angiographic syringe manufacturing failures
The US Food and Drug Administration (FDA) has issued a warning to Medline over deficiencies relating to the company’s angiographic…
09 Apr 2026
MiRus treats first patients in STAR trial of Siegel 8-French heart valve
MiRus has enrolled and treated the first patients in the Siegel transcatheter aortic valve replacement (STAR) trial evaluating the Siegel 8-French aortic transcatheter heart valve (THV) for severe, symptomatic aortic…
09 Apr 2026
CorTec gains FDA breakthrough designation for stroke rehabilitation BCI
CorTec’s brain-computer interface (BCI) has obtained breakthrough device designation from the US Food and Drug Administration (FDA) for use in stroke rehabilitation. Under development for brain-based communication and neural recording,…
09 Apr 2026
MHRA secures $4.8m to expand AI medical device programme
The Medicines and Healthcare products Regulatory Agency (MHRA) has secured a £3.6m ($4.8m) funding increase over three years to expand the AI Airlock programme, the UK’s regulatory sandbox for AI…
08 Apr 2026
FDA approves Endospan’s aortic stent
Israel’s Endospan has received US Food and Drug Administration (FDA) approval for the NEXUS aortic graft stent system, priming the company for the US commercialisation of the aortic arch dysfunction…
08 Apr 2026
Route 92 Medical raises $50m to support growth strategy
Route 92 Medical has secured $50m in financing to support the next phase of its growth strategy. New investor Sectoral Asset Management joined lead investor Novo Holdings, along with returning…
08 Apr 2026
E2 raises $80m to advance VTE system’s commercialisation
Endovascular Engineering (E2) has raised $80m to advance commercialisation efforts for Hēlo, a platform for venous thromboembolism (VTE) treatment. The California-based company’s oversubscribed Series C financing round was co-led by…