By Carolyne Hathaway, Rebecca Brandt, Elizabeth Richards and John Manthei
Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European for its percutaneous aortic valve replacement system, CoreValve.
The device is "the only transcatheter aortic valve available in the world that can treat – without surgery – patients with larger valve openings (up to 29mm)," according to a press release.
CoreValve is the largest transcatheter valve available, but can compress into a small delivery system to be deployed in the same delivery system as smaller CoreValve sizes.
The FDA set an August 23 date for a final rule for three "fallen angel" class III devices to submit premarket applications or be taken off the market as their existing 510(k) cleared status has been revoked.
The term "fallen angel" refers to medical devices that were once candidates for the FDA’s fast-track 510(k) review but have since been relegated to the more stringent premarket approval path.
Cancer diagnostics firm Neoprobe Corp. (NYSE Amex:NEOP) pressed past the controversy surrounding its Lymphoseek radiopharmaceutical and submitted a new drug application for FDA review.
The Dublin, Ohio-based company hopes to win clearance for Lymphoseek for use in intraoperative lymphatic mapping, a surgical procedure that identifies and biopsies lymph nodes for traces of cancer.
In a new draft guidance issued today the FDA sought to clear up confusion about what types of changes to existing medical devices require new 510(k) submissions.
The watchdog agency outlined changes to the device features, such as labeling, manufacturing and materials, which require a new 510(k) submission, as well as what types of changes don’t need additional agency review.
Total review times for 510(k) submissions have increased by more than 55 percent since 2005 because of poor quality submissions by medical device manufacturers, the FDA said today.
FDA CDRH chief Dr. Jeffrey Shuren addresses the
audience in a live Q&A
Hundreds of representatives from New England’s medical device industry gathered last night at the MassDevice Big 100 Regional Roundtable at the Westin Hotel in Waltham, Mass., to share their experiences and ideas for the industry’s future.
MASSDEVICE ON CALL — Medical device consulting firm Emergo Group released results from a study of the U.S. Food & Drug Administration’s medical device application review, finding that application times jumped 37 percent from 2006 to 2010.
Emergo reviewed the number of submissions the FDA clears each year and how long it takes to win 510(k) clearance to obtain an average "submission to clearance" time.
In 2006 510(k) applications cleared by the FDA took an average of 96 days, but that number jumped to 132 days in 2010.
ReGen Biologics Inc. sued the FDA, its top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds in rescinding a clearance for ReGen’s Menaflex knee implant earlier this year.
Dr. Jeffrey Shuren, head of the FDA’s medical device arm, said a Northwestern University survey on the 510(k) clearance program “validates actions we are already taking” to improve the regulatory path for almost all medical devices.
“These efforts may not grab headlines, but they represent true actions we’re taking to promote innovation and protect the public health,” Shuren told an audience in Washington, D.C. this morning following a presentation of the survey results. “The 510(k) program has to adjust, but it has to adjust properly.”
Increasing numbers of medical device makers will look offshore to introduce new medical technologies unless the FDA can make its 510(k) review process more predictable, according to researchers from Northwestern University.