April 9, 2015 by Brad Perriello
The FDA today issued its final guidance on a new, fast-track approval protocol for medical devices aimed at deadly or debilitating illnesses with no treatment options.
The safety watchdog’s Center for Devices & Radiological Health said its Expedited Access Program allows companies with devices for life-threatening or irreversibly debilitating conditions, that would normally be subject to the stringent pre-market approval process or the de novo clearance program, to ask for fast-tracking at the agency. Read more
April 10, 2015 by Brad Perriello
CardiAQ Valve Technologies today said it won a nod from the FDA for an early feasibility trial of its 2nd-generation transcatheter mitral valve implant.
The 20-patient trial will enroll 10 subjects to be treated transfemorally and another 10 treated via the transapical approach, Irvine, Calif.-based CardiAQ Valve said. Boston’s Beth Israel Deaconess Medical Center will serve as the core lab for the study, the company said. Read more
April 10, 2015 by Mark Hollmer
HemCon Medical Technologies gained Chinese regulatory approval to start selling wound care products in the world’s largest nation.
HemCon, now a subsidiary of TriStar Wellness Solutions, will sell its full roster of wound care products in the People’s Republic. The Oregon-based company said it has already entered the China market this month by accepting an order through a distributor there. Read more
April 9, 2015 by Mark Hollmer
HeartWare International plans to start marketing its implantable heart pump in Canada as a bridge to transplant for patients with end-stage heart failure, in the wake of a regulatory sign-off for the device.
The Framingham, Mass.-based company said today that Health Canada approved its left ventricular assist device. President & CEO Doug Godshall said the company is now looking forward to “demonstrating the benefits of the HeartWare System in a larger patient population in Canada.” Read more
April 7, 2015 by MassDevice
Hospira, which agreed in February to be bought by Pfizer, said the FDA sent it another warning letter detailing violations in standard drug manufacturing practices at 1 of its facilities.
The FDA said its inspectors had visited the company’s plant in Liscate, Italy, twice in May last year and identified significant violations, including a failure to establish procedures to prevent contamination and to thoroughly investigate instances where a batch did not meet specifications. Read more