The Medical Device Business Journal — Medical Device News & Articles | MassDevice
St. Jude Medical Inc. (NYSE:STJ) announced a med-tech first with a European CE Mark approval for its Genesis implanted neurostimulation device for patients with chronic migraines.
Genesis, which is the first device of its kind to win regulatory approval in any market, provides peripheral nerve stimulation to the occipital nerves to manage migraines. Small electrical leads are placed under the skin and connected to a device which produces pulses of stimulation.
MASSDEVICE ON CALL — A series of high-profile drug and device recalls has locked the FDA in defense mode, making standard review processes more difficult, venture capitalists say.
The unpredictability and threat of longer review times may be making investors more wary of putting their faith and their dollars into med-tech.
Here’s the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more recent hirings and firings, check out MassDevice’s compilation of the latest personnel moves.
A U.S. House subcommittee hearing yesterday on the FDA’s oversight of medical devices devolved along sadly predictable party lines, with Republicans charging that the federal watchdog agency is strangling med-tech innovation and Democrats looking to undermine the reports behind the GOP’s arguments.
Which is too bad, because all the political noise obscured the real and pressing cause behind any problems at the Center for Devices & Radiological Health.
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:
Gulfo
Mela Sciences (NSDQ:MELA) CEO Dr. Joseph Gulfo raised $130 million, lead what he calls the “largest prospective clinical study ever conducted in melanoma detection” and developed a product he believes can help make a dent in the thousands of deaths that happen every year from skin cancer, but he can’t get his calls answered by the FDA.
After nearly two years of waiting for an answer from the FDA on its hand-held biopsy device for skin cancer, Mela Sciences (NSDQ:MELA) is taking to the streets.
Mela Sciences Inc.’s (NSDQ:MELA) stock doubled in price overnight after the a Food & Drug Administration panel voted in favor of its melanoma-detecting device’s safety and efficacy.
MELA shares were up 105.5 percent to $5.24 before the trading day opened. Through yesterday’s close, the shares lost 60 percent of their value in the past three months. The company’s shares’ gain remained around 95 percent up in mid-morning trading.
Mela Sciences Inc.’s (NSDQ:MELA) hand-held skin cancer detection device received a scathing review from the the Food & Drug Administration.
The Irvington, N.Y.-based company’s MelaFind, a device designed to determine whether skin moles and lesions are cancerous — potentially eliminating the need for biopsies — is scheduled for a vote by the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee this week, which could pave the way for the device’s final pre-market approval.
The Food & Drug Administration has finally set a panel date for the MelaFind, a hand-held device designed to determine whether skin moles and lesions are cancerous, possibly eliminating the need for biopsies.
The agency’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee set a Nov. 18 date for MELA Sciences Inc. (NSDQ:MELA), the Irvington, N.Y.-based maker of the device, which originally filed a pre-market approval application with the federal watchdog in June 2009, more than 14 months ago.
