As devices come onto the market that have to follow the new FDA guidance of SBOMs and patching, backdoors may become easier to prevent and detect.

Intuitive Surgical announced today that the FDA cleared the latest advanced energy instrumentation for its da Vinci systems.

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate ...

Synchrony Medical announced that it received FDA 510 (k) clearance for its LibAirty airway clearance system.

A polymer-based device cleared by the FDA offers physicians a new way for repairing peripheral nerve injuries.

The FDA has cleared the Hilo Band (G0 Blood Pressure Monitoring System) for at-home blood pressure monitoring in adults.

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

Generative AI chatbot for doctors called 'Prof. Valmed' earns E.U. approval. In the U.S., FDA is yet to issue guidelines on the technology's use in medicine.

Q’Apel Medical, Inc. announced it has received FDA clearance for the Zebra neurovascular access system, which is indicated fo ...

In medical instrument and device production, surface finish is a critical factor in safety, functionality and regulatory compliance. That’s where Vapormatt’s patented wet blasting technology delivers ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These are the key takeaways.