After a disappointment with the same product in another indication about two years ago, Sensorion SA met the primary endpoint in its proof-of-concept phase IIa trial with SENS-401 for residual hearing preservation after cochlear implant.

Watertown, Mass.-based Lyndra Therapeutics Inc. is seeking patent protection for gastric residence drug delivery systems with improved shelf lives through their inclusion of a metal core.

Roche AG debuted a new continuous glucose monitor (CGM) at the Advanced Technologies & Treatments for Diabetes conference in Florence, Italy, last week, but how appealing users will find it remains unclear – as is the market opportunity given the entrenched position of Abbott Laboratories and Dexcom Inc.

The U.K. government said it will take action to tackle potential bias in the design and use of medical devices after an independent review found that there is extensive evidence of poorer performance of certain technologies, like pulse oximeters, in patients with darker skin tones.

This year’s annual meeting of the International Medical Device Regulators Forum (IMDRF) revolves around regulatory reliance, a notion that approaches but does not quite stray into the realm of the mutual recognition agreement.

U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence (AI).