The FDA sent an early safety alert warning clinicians of deployment failures with certain Boston Scientific AXIOS Stent and ...

The company’s iotaSOFT surgical robot for cochlear implantation can now be used for performing this procedure in patients as ...

A large multicenter clinical trial led by King's College London with 150 children and adolescents has shown that a device cleared by the US FDA to treat ADHD is not effective in reducing symptoms.

FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.

The alert concerns reports of Prismaflex control units falling out of their upright positions, potentially triggering an ‘Air ...

A major American medical device manufacturer is investing $110 million to expand production in Nebraska as part of an effort to restore pharmaceutical manufacturing and improve ...

The expanded 510 (k) clearance is publicly available in the FDA's 510 (k) Premarket Notification database under device number K253939.

Medtronic said Monday it received 510 (k) clearance from the Food and Drug Administration for an app to connect its smart ...

Singular Health has jumped a major regulatory hurdle after winning fast-tracked FDA clearance in the US for its 3DICOM MD ...

A new breath-based sensor entering human trials now suggests the underlying technology may finally be catching up with ...