TCI SEEKS TRACKING EXEMPTION FOR HEARTMATE LVAS
This article was originally published in The Gray Sheet
Executive Summary
TCI SEEKS TRACKING EXEMPTION FOR HEARTMATE LVAS in a July 29 petition to FDA. The current indication for use of the implantable pneumatic left ventricular assist system (IP LVAS) as a temporary device to be used only in a hospital setting, Thermo Cardiosystems Inc. argues, should allow it to be exempted from medical device tracking requirements.
You may also be interested in...
Prestige Expands UK Eye Care Range In Response To Consumer Demand
A “great consumer response” to TheraTears in the UK leads Prestige Consumer Healthcare to add TheraTears 5-in-1 Irritation and Redness eye drops to the range.
Who’s Hired? Hikma Recruits New US Generics President
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.