April 21, 2017

FDA Clears Lifetrack Medical Systems Next Generation PACS for Distributed Radiology

Philippines–based Lifetrack Medical Systems has won FDA marketing clearance for its Lifesys picture archiving and communication system. Widely available in Asia, the product is now being rolled out in the U.S. and in other global markets.

Medtronic Updates Faulty HVAD Pump Controller

Medtronic is replacing a faulty controller for its HVAD pump for heart failure, which was linked to a Class 1 product recall.

The updated controller—approved by the FDA on April 7—addresses several, previously reported potential safety issues, Medtronic says.

Esophageal Cooling Device Wins FDA 510K Approval

Chicago-based Advanced Cooling Therapy has won FDA pre-market approval for its esophageal cooling device.

FDA Clears Additive Orthopaedics Locking Lattice Plating System

New Jersey–based Additive Orthopaedics has received FDA marketing clearance for its 3D printed Locking Lattice plating system. The device is designed to assist in stabilization and fusion of fractures, osteotomies and arthrodesis of small bones.

gammaCore Receives FDA Clearance for Treating Cluster Headache Pain

New Jersey–based electroCore has gained FDA clearance for gammaCore, a non-invasive vagus nerve stimulator for the acute treatment of pain associated with episodic cluster headache in adult patients.

The company expects to market gammaCore in the U.S. early in the third quarter of 2017.

Monitored Therapeutics Wins FDA Clearance for Home-Use Spirometer

Ohio–based Monitored Therapeutics has received FDA marketing clearance for its GoSpiro Home Spirometer.

Ethicon Receives FDA Clearance for Echelon Circular PowerEd Stapler

Cincinnati–based Ethicon has received FDA marketing clearance for its Echelon circular-powered stapler. The device is designed to reduce anastomotic complications in colorectal, gastric and thoracic cancer surgeries.