Saturday, September 14, 2019

Saturday, September 14, 2019

Latest News

LifeKit Prevent Test earns Breakthrough Device designation from FDA

The Food and Drug Administration (FDA) has granted a submission for a Breakthrough Device designation from Prescient Metabiomics for its LifeKit Prevent Colorectal Neoplasia Test for the early detection of colon polyps and colon cancer.

FDA creating new labeling guidelines for opioid medications

The FDA has issued new draft guidance for labeling of prescription medications that could be abused, with the goal of making the risks of dependence clearer for health care providers and for patients.

EBR SYSTEMS, INC.: FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure.

CHECKPOINT SURGICAL: Receives FDA Breakthrough Designation for Nerve Regeneration Device

Checkpoint Surgical, Inc., a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief electrostimulation therapy (BEST) system.

FDA Reporter