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Pre-Market Approval (PMA)

Covidien’s SpiderFX wins FDA clearance | Regulatory Roundup

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Covidien SpiderFX

SpiderFX embolic protection device

Covidien (NYSE:COV) landed 510(k) clearance for its SpiderFX system to treat severely calcified lesions in the lower extremities.

The Mansfield, Mass.-based med-tech titan’s system has been on the European market since 2005 and is currently the only embolic protection device indicated for use in the lower extremities in the U.S.

FDA releases October PMA approvals

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FDA logo

PMA Original Approvals

FDA approves Boston Scientific’s Promus Element stent

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Stent Wars

Shares of Boston Scientific (NYSE:BSX) rose nearly 7 percent in pre-market trading today after the FDA approved its Promus Element drug-eluting stent, inaugurating a head-to-head battle between two of the last giants left standing in the Stent Wars.

J&J’s Ethicon Endo-Surgery gets appeal date for Sedasys denial

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FDA

Ethicon Endo-Surgery’s Sedasys system, which the agency declined to green-light in 2010, will go before an agency panel in December to plead for approval one more time.

The Johnson & Johnson (NYSE:JNJ) subsidiary is slated to appear before the FDA’s Medical Devices Dispute Resolution Panel to consider the FDA’s denial of the device on grounds that EES failed to prove Sedasys is safe enough for the U.S. market.

Brain stimulation tech gets a date with the FDA

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FDA

The FDA set a date in February for the public meeting on whether cranial electrotherapy stimulators need increased regulatory oversight.

The devices, heretofore cleared for the U.S. market via the 510(k) process, apply electrical currents to the brain through the skin for the treatment of anxiety, depression, insomnia and pain.

GE Healthcare begins PMA process for 3D breast scanner | Regulatory Roundup

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GE Healthcare's Senographe Essential

GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.

The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.

Edwards and Medtronic tout regulatory approval for transcatheter valve treatments

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Medtronic Inc. (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) both got the thumbs up for their heart valves from regulatory bodies, but Edwards is ahead of Medtronic in bringing a device to the U.S. market with FDA approval to expand clinical trials of its Sapien system.

Mela Sciences CEO: MelaFind rollout planned for early 2012

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Dr. Joseph Gulfo, CEO of Mela Sciences (NSDQ:MELA), says the company plans to begin rolling out its MelaFind skin cancer detection system during the first quarter of 2012, after winning a hard-earned green-light from the FDA.

"I don’t think we’ll be ‘selling,’ in the classic sense of selling, for at least a year and a half," Gulfo told MassDevice. "Dermatologists want this system, so we don’t need to ‘sell’ it.

MELA Sciences lands FDA clearance for MelaFind

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MELA Sciences

More than two years, two panel reviews and one citizen’s petition after Mela Sciences (NSDQ:MELA) signed on for a 6-month FDA review of its MelaFind melanoma detection system, the company won FDA clearance for the U.S. market.

The Irvington, N.Y.-based company’s shares shot up 5 percent on the news, to $5.63, from last night’s close at $5.39.

MELA Sciences lands FDA clearance for MelaFind

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Melanoma is the deadliest form of skin cancer, responsible for approximately 75% of skin cancer fatalities

 IRVINGTON, NY (November 2, 2011) – MELA Sciences (NASDAQ: MELA) today announced that the U.S. Food and Drug Administration (FDA) has approved the pre-market approval (PMA) application for MelaFind®.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
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