TCTMD13h
J&J Restarts Varipulse Pulsed-Field Ablation Cases in the US
The instructions for use have been updated to address issues that led to a greater risk of neurovascular events in an early ...
STAT12h
FDA’s head of device safety among employees terminated in ‘challenging’ weekend
The cuts hit the FDA's medical device center particularly hard, including reviewers and experts on AI-enabled medical ...
BioWorld6h
J&J resumes US Varipulse sales, but will it matter?
Nearly six weeks after Johnson & Johnson paused the U.S. external evaluation of its Varipulse pulsed field ablation catheter ...
Becker's Spine Review10h
Life Spine earns FDA clearance for cervical plating system
Medical device company Life Spine has earned FDA clearance for its Gruve+ cervical plating system. The design integrates with Life Spine’s cervical spacers, according to a Feb. 18 press release.
clinicaladvisor.com14h
Susvimo Approval Expanded to Include Diabetic Macular Edema
The Food and Drug Administration (FDA) has approved Susvimo ® (ranibizumab injection) for the treatment of patients with diabetic macular edema (DME) who have previously responded to at least 2 ...
medtechdive11h
Medtronic nears FDA submission for Hugo robot
CEO Geoff Martha said Medtronic would submit its application for urological procedures to the Food and Drug Administration by ...
JD Supra10h
FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care ...