FDA advisory committee: EDAP's Ablatherm PMA falters at adcomm over poor efficacy data
GAITHERSBURG, Maryland The Ablatherm PMA by EDAP (Lyon, France) faltered at a July 30 FDA advisory committee despite that the device has been available in Europe for more than a decade, raising questions once again about FDA's higher regulatory standards and the agency's willingness to accept outside-U.S. data for device applications. Enrollment issues associated with the pivotal trial for the Ablatherm device, which boasts more than 20,000 uses in OUS settings, forced the sponsor to make use of a post-hoc analysis assembled prior to completion of the trial, but the panelists largely brushed aside what some said was a reasonable safety record in an 8-0 vote that the benefits do not outweigh the risks.
Unapproved changes: Recent FDA warning letters
FDA's warning letters to device makers serve as vehicles for all kinds of statements, including statements about when a device maker needs a new regulatory filing. Lately it seems that has come up a lot more, but is that a trend or just a blip on the screen?
ReWalk Robotics secures FDA clearance for exoskeleton for paraplegic patients
In 1997, Amit Goffer, an Israeli inventor, was severely paralyzed as a result of an ATV accident. Not content with his condition or the level of innovation available for paralyzed patients, Goffer, who is now a quadriplegic, began work on mobility devices. His work paid off as he eventually developed an exoskeleton to help paraplegic patients walk.