Healthcare Dive

Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA

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 ...
Firehouse

ZOLL Receives PMA Approval For ResQCPR System

ZOLL Medical Corporation announced the company’s ResQCPR System has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) to market and begin U.S. distribution of the ...
Seeking Alpha

NeuroPace Files PMA Supplement to FDA Seeking Expanded RNS® System Indication for Idiopathic Generalized Epilepsy

-- 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 ...
Yahoo Finance

FDA Files Rejoni’s Juveena® Hydrogel System PMA for the Prevention of Intrauterine Adhesions

BEDFORD, Mass., January 13, 2026--(BUSINESS WIRE)--Rejoni, Inc., a clinical-stage company focused on uterine health, today announced that the U.S. Food and Drug Administration (FDA) has completed its ...
Yahoo Finance

Companion Spine Announces FDA Premarket Approval ("PMA") of the DIAM™ Spinal Stabilization System for the Treatment of Degenerative Disc Disease ("DDD")

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 ...
Business Insider

TransMedics, Inc. Receives FDA Pre-Market Approval (PMA) for its OCS™ Lung System for Near-Physiologic Preservation and Assessment of Lungs for Transplantation

ANDOVER, Mass., April 12, 2018 /CNW/ -- TransMedics, Inc., a medical technology company that is transforming the important therapy of solid organ transplantation for patients with end-stage lung, ...