FDA News Briefs for Wednesday, February 21, 2018February 21, 2018
These Food and Drug Administration (FDA) developments came in this week:
FDA Clears UroLift System for Use in Expanded Patient Population
The FDA has cleared the UroLift System (NeoTract) for the treatment of urinary outflow obstruction due to benign prostatic hyperplasia (BPH) in men as young as 45 years old, including those who have an obstructive median lobe. Previously, the UroLift System was contraindicated in patients with an obstructive median lobe and only cleared by the FDA for use in men 50 years of age or older. More Information.
CorPath GRX System Now Cleared for Peripheral Vascular Intervention
Corindus Vascular Robotics, Inc. announced on Monday that it received 510(k) clearance from the FDA for use of its CorPath GRX System in peripheral vascular interventions. Previously, the CorPath GRX system was cleared for use in treating coronary artery disease. More Information.
FDA Recalls Accu-Chek Connect Diabetes Management App
The FDA recently announced a recall of Roche Diabetes Care Inc.’s Accu-Chek Connect Diabetes Management App, because of a software bug in the Bolus Advisor feature. The agency identified this action as a Class 2 device recall. More Information.