The Food & Drug Administration released a list of pre-market approvals granted in June:
PMA Original Approvals
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
The Food & Drug Administration released a list of pre-market approvals granted in June:
PMA Original Approvals
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III devices to submit premarket applications or be taken off the market as their existing 510(k) cleared status has been revoked.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.
The FDA released a new guidance today detailing the agency’s process of making benefit-risk determinations when assessing premarket applications for medical devices for "reasonable assurance of safety and effectiveness."
The agency hopes to provide clarity for both industry and its reviewers by outlining what sorts of factors are taken into consideration when considering PMAs, the most stringent of the medical device review processes.
The Food & Drug Administration released a list of pre-market approvals granted in May:
PMA Original Approvals
Following last week’s draft guidance recommending that pacemakers be reclassified as Class III devices that require premarket approval for FDA review, the watchdog agency released a new proposed rule today that would put the external devices used to alter a pacemaker’s electrical operating performance in the same category.
Pacemaker programmers non-invasively communicate with the implanted device to modify the rate of pacing or other operating characteristics.
The FDA unveiled a new draft guidance today recommending that class III implantable pacemaker pulse generators be required to submit premarket approval applications or submit notice of completion of product development protocols.
"The Cardiovascular Devices Panel recommended that the implantable pacemaker pulse generator (which includes the internal pacemaker battery) be classified into class III because the device is implanted and life-supporting and presented a potential unreasonable risk of illness or injury," the guidance finds.
The House Energy & Commerce Committee’s oversight subcommittee is set to examine the FDA’s performance in clearing medical devices for the U.S. market in a hearing set for this week on Capitol Hill.
On July 20, the GOP-led committee will hold its “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs” at 10:30 a.m.
The committee said it will look at the following issues:
Updated: 7/19/2011 12:15 p.m.
The Sapien transcatheter heart valve, made by Edwards Lifesciences Corp. (NYSE:EW), seems poised for a favorable vote from an FDA panel, despite study results that show patients receiving the device have an increased risk of stroke.
Medtronic Inc.’s (NYSE:MDT) got the go-ahead to pursue trials of its Symplicity catheter system for treating hypertension via renal denervation.
The system includes a catheter inserted into the renal artery near each kidney via the femoral artery in the upper thigh. A generator on the tip of the catheter delivers lower-power radio-frequency energy to "deactivate" the sympathetic nerves, lowering blood pressure.
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.
Edwards Lifesciences Corp. (NYSE:EW) is confident that its flagship Sapien transcatheter heart valve device will have a quicker uptake in the U.S. than it did in Europe.
Speaking at an investors conference in Boston, Edwards’ vice president of investor relations David Erickson said the company has several advantages in the U.S. market that it didn’t have when it launched the Sapien device in Europe four years ago.