News Briefs: FDA Program Alignment Group; CardioMEMS Panel; HCV Coverage Analysis
This article was originally published in The Gray Sheet
Executive Summary
FDA announces the formation of a new Program Alignment Group, made up of center directors and other officials, and schedules an workshop on intraocular lenses. The agency’s Circulatory System Devices panel will review CardioMEMS’ pulmonary monitoring system again and Medtronic devices. CMS opens coverage analysis for hepatitis C screening. More news.
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Medtronic Takes Aim At Implantable Device Infections with TYRX Buy
The $160 million cash acquisition fits with the firm’s efforts to fashion itself into a health care services and solutions company, rather than pure device firm. TYRX makes anti-bacterial envelopes for implanted devices, and has FDA clearances with cardiac implantable electronic devices and spinal cord neurostimulators.
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