Epitomee Medical Ltd submitted its application to the U.S. FDA for 510k regulatory clearance for its swallowable weight loss capsule. It joins a host of companies offering solutions to the global obesity crisis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Edwards, Heartflow, Heartsciences, Medtronic, Merakris.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affluent Medical, Assure Holdings, Beckman Coulter, Betters Medical, Biocardia, Cara Cara, Clario, Emboline, Fujirebio, GE Healthcare, Hidoc, Mahana, Metabolon, MpowerHealth, Philips, Rhythm AI, Spectral AI, SS Innovations, T2 Biosystems.
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.
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