As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.

GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing ...

The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML-Enabled ...

Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the successful closure of a $55 million funding round from the company's existing investment ...

Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and "unleash AI." ...

Safe Group announces FDA 510(k) clearance for SpineUp's Frida solution Fleurieux-sur-l'Arbresle - France - June 5, 2025 at 6 p.m. Safe Group, a leading player in the field of medical devices for spine ...

Credit: Penumbra/PR Newswire. Penumbra has introduced Ruby XL System, the detachable embolisation coil, which has also received clearance from the US Food and Drug Administration (FDA). The system is ...

The firm opines the device makers look a safer bet because they are not caught up in the debate about lower drug prices, following Donald Trump’s ‘Most Favoured Nation’ (MFN) decree (see below).