Category: FDA

FDA requires nine makers of needleless connectors to conduct post-market surveillance

July 29, 2010 by MassDevice staff

The U.S. Food & Drug Administration said it is requiring nine medical device companies to conduct postmarket analysis on a connection between needless connectors and higher rates of blood stream infections.

In a notice posted on the Centers for Devices and Radiological Health web site, officials said that the agency is "aware of information that raises concerns about the safety of positive displacement needleless connectors."

FDA plans workshop on medical device innovation

May 27, 2010 by MassDevice staff

As part of its ongoing attempt to remove bureaucratic impediments from the development of medical devices, the Food & Drug Administration is planning a public workshop to address innovation in the medical device industry June 24 in Washington.

Double win for Boston Scientific's balloon catheter

May 25, 2010 by MassDevice staff

Boston Scientific Corp. (NYSE:BSX) garnered both a CE Mark and Food & Drug Administration pre-market approval for its NC Quantum Apex PTCA dilation balloon catheter.

The post-dilation device is designed to optimize coronary stent deployment; according to the company's POSTIT study, the device improves the accuracy of stent deployment compared with a stent delivery balloon alone.

X-spine wins FDA nod for spinal screw system

May 24, 2010 by MedCity News

By Mary Vanac

X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to sell its Fixcet spinal facet screw system.

Fixcet is used to stabilize the spine during spinal fusion procedures, such as treatment of degenerative disk disease, the company said in a press release. Facets are the wing-like bones on the backside of spinal vertebrae.

Medical device makers give FDA official an earful

May 20, 2010 by Minnesota Publi...

By Martin Moylan

Bloomington, Minn. — The federal official who oversees the review and approval of medical devices came to the Twin Cities May 18, to hear what industry leaders and medical experts have to say about how the agency is doing its job. They aired a host of complaints.

FDA aims to make approvals process more transparent

May 20, 2010 by MassDevice staff

The Food & Drug Administration is proposing to expand the amount of information it reveals about its approvals process for medical devices and drugs, including revealing applications for investigational device exemptions and when it denies applications.

The 21 proposed changes, released May 19, are already drawing fire from industry. AdvaMed, the national lobby for the medical devices industry, said the proposed changes would weaken intellectual property protections and stifle innovation.

CDRH chief Shuren heads to Mass. for town hall meeting

May 4, 2010 by MassDevice staff

Dr. Jeffrey Shuren, director of the Food & Drug Administration's medical device oversight arm, will present the Center for Devices and Radiological Health's priorities for the upcoming fiscal year, which include facilitating innovation and increasing transparency.

The FDA branch launched a transparency website in April to share information about its decisions on medical devices and radiation-emitting products. The CDRH is also hoping to address how the FDA engages with the medical device industry.