The Juveena Hydrogel System is designed as a temporary spacer to help prevent the formation and reformation of intrauterine adhesions (IUAs). The PMA submission includes results from a pivotal ...
CSA Medical, Inc., a medical device company focused on interventional pulmonary therapies, today announced the submission of ...
Medtronic's HeartWare HVAD pump system has been hit with a slew of recalls in recent months and the rate of device malfunction reports documented since it's been on the market in an FDA database ...
MÉRIGNAC, France, December 15, 2025--(BUSINESS WIRE)--Companion Spine, the French-American specialist in surgeon innovated spine implant surgery, announced that the U.S. Food and Drug Administration ...
GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous ...
Getinge AB received U.S. FDA premarket approval (PMA) for its Icast covered stent system, which has been used by clinicians for 20 years under the brand name Advanta V12. Icast is designed to treat ...
Companion Spine Announces FDA Premarket Approval (“PMA”) of the DIAM™ Spinal Stabilization System for the Treatment of Degenerative Disc Disease (“DDD”) DIAM™ Spinal Stabilization System is the first ...
Companion Spine, the French-American specialist in surgeon innovated spine implant surgery, announced that the U.S. Food and Drug Administration (the “FDA”) has approved the DIAM™ Spinal Stabilization ...
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