MCAC schedules TMR/PMR review
This article was originally published in The Gray Sheet
Executive Summary
Medicare Coverage Advisory Committee will meet July 14 to discuss and make recommendations regarding transmyocardial revascularization and percutaneous myocardial revascularization for severe angina. Medicare currently covers TMR performed by PLC's CO2 Heart Laser and CardioGenesis' CardioGenesis 2000 for symptomatic relief of severe, medical refractory angina. CardioGenesis is developing a PMR system (1"The Gray Sheet" March 29, 2004, In Brief)...
You may also be interested in...
PMR back to the drawing board
CardioGenesis will not seek an FDA Medical Devices Dispute Resolution Panel review, following an unapprovable determination by the agency on the firm's PMA supplement for percutaneous myocardial revascularization (PMR). Further clinical work to gain approval will be considered during a future meeting with FDA, the company says. CardioGenesis cancelled an August 2003 dispute resolution panel review in an attempt to reconcile its clinical data directly with the agency (1"The Gray Sheet" June 2, 2003, p. 6). While CardioGenesis has not completely abandoned the notion of a future dispute panel review, the firm will focus on securing approval in Europe, Canada and Australia. CardioGenesis shares plummeted 29% on the news, closing at $0.74 on March 25...
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.