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 ...
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 ...
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

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 ...
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 ...
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,” ...