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 ...
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

CSA Medical Submits PMA for RejuvenAir® System Following Positive Results from Pivotal SPRAY-CB Trial

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 ...
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 ...
Morningstar

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

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 ...
Business Insider

CardioFocus Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System

MARLBOROUGH, Mass., Feb. 4, 2020 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company ...
Business Wire

TherOx Announces Its PMA Application for AMI Therapy System is Accepted for Filing by FDA

IRVINE, Calif.--(BUSINESS WIRE)--TherOx, Inc., a privately held medical device company focused on improving treatment of Acute Myocardial Infarction (AMI), announced that the U.S. Food and Drug ...
Business Wire

Senseonics Submits PMA Application for 180-Day Eversense System to the FDA

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 ...
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 /PRNewswire/ -- TransMedics, Inc., a medical technology company that is transforming the important therapy of solid organ transplantation for patients with end-stage ...
Rutland Herald

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

“FDA PMA of DIAM™ Spinal Stabilization System is a landmark moment in the evolution of Companion Spine as a company solely focused on Total Disease State Solutions™ for degenerative spine diseases,” ...
VentureBeat

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

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 ...