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 ...

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

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 ...
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 ...
FiercePharma

FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures

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, ...
Business Wire

Endologix Submits Premarket Approval (PMA) Application to FDA for the

IRVINE, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives by providing disruptive therapies for the interventional treatment ...
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 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 ...