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 ...
-- Submission supported by positive preliminary 18-month NAUTILUS data in patients with drug-resistant idiopathic generalized epilepsy (IGE) and generalized tonic-clonic (GTC) seizures -- The PMA-S is ...
BOSTON, Jan. 7, 2026 /PRNewswire/ -- CSA Medical, Inc., a medical device company focused on interventional pulmonary therapies, today announced the submission of a Premarket Approval (PMA) application ...
ANDOVER, Mass., April 12, 2018 /PRNewswire/ -- TransMedics, Inc., a medical technology company that is transforming the important therapy of solid organ transplantation for patients with end-stage ...
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 ...
FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures Reduces risks associated with oversedation, ...
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 ...
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 ...
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