The FDA issues an "approvable letter" to Mela Sciences after its years-long battle for a U.S. green light for its hand-held skin cancer detection device, the MelaFind, sending the company's shares up more than 90 percent in pre-market trading.
Shares of Mela Sciences (NSDQ:MELA) are on a tear today in pre-market trading on news that the FDA issued an "approvable letter" for its MelaFind skin cancer detection device.
The Irvington, N.Y.-based company is more than two years into a six-month review of its pre-market approval application for the device, which uses a multi-spectral dermascope to make under-the-skin lesions visible to physicians. In June, CEO Dr. Joseph Gulfo told MassDevice that the company was an unintended victim of the push for reforms at the FDA's Center for Devices & Radiological Health.
"We're collateral damage in the efforts to re-design the 510(k) program," Gulfo told us. "I'm just being a megaphone for transparency."
That appears to no longer be the case with the issuance of the approvable letter, according to Mela Sciences.
"The FDA's approvable letter for MelaFind represents a monumental milestone for Mela Sciences and the millions of Americans who are at risk of developing Melanoma, the deadliest form of skin cancer," Gulfo said in prepared remarks. "We are extremely pleased with the FDA's decision and will work diligently to answer all open questions and finalize the post-market study protocol in the coming weeks."
NxStage Medical says it won 510(k) clearance from the FDA for nocturnal home hemodialysis treatments...
The Centers for Medicare & Medicaid Services will officially remove national coverage decisions...
The FDA grants 510(k) clearance for Bio2 Technologies' CLM bioactive scaffold wedges.
The U.S. Defense Dept. agrees to pay Meridian Medical Technologies $130 million to develop auto-...