Novoste Meeting With FDA On Beta-Cath Labeling Issues Week Of Oct. 23
This article was originally published in The Gray Sheet
Executive Summary
Preparations for the U.S. launch of Novoste's Beta-Cath intracoronary radiation catheter system to treat in-stent restenosis are nearly complete, and the firm hopes to receive final FDA approval in time for the American Heart Association meeting in mid-November. The company reported receiving an "approvable" letter from the agency on Oct. 16.
You may also be interested in...
Boston Sci Stent Development Proceeding In-House; J&J Velocity Moves Fast
Boston Scientific is pursuing the development of its next-generation coronary stent platform internally as well as with partner Medinol as a contingency to the ongoing uncertainties with the Israeli firm.
Boston Sci Stent Development Proceeding In-House; J&J Velocity Moves Fast
Boston Scientific is pursuing the development of its next-generation coronary stent platform internally as well as with partner Medinol as a contingency to the ongoing uncertainties with the Israeli firm.
Device Malfunctions Reported In Beta-Cath PMA Submission Not Significant
A number of "minor device malfunctions" reported in Novoste's Beta-Cath radiation system premarket approval application do not detract from the device's efficacy, members of FDA's Circulatory System Devices Panel agreed Sept. 11.