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.
"We’ve seen a pretty steady and significant decline in early stage investment in med devices that really isn’t there for the rest of the industry," Dow Jones VentureSource global research director Jessica Canning told CNN. "And what it essentially boils down to is that uncertainty strangles innovation."
The FDA has repeatedly denied any internal culture change that would put medical devices in a more difficult position, but MelaSciences CEO Joe Gulfo’s tale of a sudden shift in the company’s relationship with the FDA that has left its flagship melanoma diagnostic device in limbo suggests otherwise.
Despite a 98 percent effectiveness rate in clinical trials and a step-by-step, binding agreement detailing the MelaFind device’s pathway to the U.S. market, the FDA found problems with trial data bucked the agreement.
MelaFind just won CE Mark approval in the European Union, according to the Associated Press.
Weight-loss surgery cheaper than non-operative care?
Despite the frequent need for additional operations for patients who have undergone bariatric weight-loss surgery, bariatric surgery is a more cost-effective way of handling morbid obesity than more traditional methods, according to a study published in the British Journal of Surgery.
Mass. Governor Patrick mingles with Boston’s med-tech scene
Mass. Governor Deval Patrick will joined the Mass. Life Sciences Center to launch EarlySense Inc.’s contact-free patient monitoring system at MetroWest Medical Center as EarlySense announced its move to Waltham, Mass., according to a press release.
Doctors: American Medical Assn. doesn’t speak for us
Only 13 percent of physician’s reportedly agree with the American Medical Assn.’s stance in support of President Barack Obama’s health care overhaul in a survey of 1,611 doctors by Jackson & Coker, a division of Jackson Healthcare, according to a press release.
DNA testing goes to space
Researchers plan to test a new DNA analyzer in zero gravity conditions using one of NASA’s "vomit comets," according to a press release.