Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.

The FDA has flagged J&J Medtech’s recall of its Cerepak detachable coils as Class I in the wake of one death and four serious ...

As Department of Health and Human Services (HHS) and FDA leadership continue to look for ways to boost transparency and reshape the U.S' healthcare infrastructure, the U.S. drug regulator has unveiled ...

Zimmer Biomet (NYSE: ZBH) announced today that it received FDA 510(k) clearance for its G7 acetabular system for hip ...

The FDA has approved Sisnos’s continuous glucose monitoring (CGM) system for consumer use beyond diabetes management, including weight management support. The device offers real-time glucose tracking ...

The US Food and Drug Administration (FDA) has approved Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for the treatment of patients with asymptomatic severe ...

Please provide your email address to receive an email when new articles are posted on . Think Surgical received FDA clearance for its robotic system to be used with the Persona knee system from Zimmer ...

Please provide your email address to receive an email when new articles are posted on . A transcatheter mitral valve replacement system was approved for patients at high surgical risk. The system is ...

Outset Medical plans to begin shipping the updated platform during the second quarter of 2026.

Orthopedics was the most active area over the second half of calendar 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.

Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...