-- 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 ...

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 ...

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 ...

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 ...

EDINBURGH, Scotland, Sept. 4, 2019 /PRNewswire/ -- CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has ...

Rejoni, Inc., a clinical-stage company focused on uterine health, today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and formally filed the Premarket ...