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 ...
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 ...
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 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 ...
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 ...