The best medical innovations are often those born from limitations of existing technology. Such was the case for Steven Frank, a radiation oncology expert, back in 2006 when he became interested in using post-implant MRI scans for prostate cancer patients treated with brachytherapy.

The medical device industry is no stranger to whistleblower lawsuits. In fact, these cases are so commonplace that most of the time they don’t even make the front page. I wouldn’t go so far as to say the industry is “extraordinarily corrupt” as one watchdog group claimed a couple years back (MDD, May 8, 2012), but it doesn’t help the image when almost all the leading device companies have been accused at one time or another of offering kickbacks. The latest such scandal involves Acumed, a company in the Portland area, accused of making bogus payments to doctors and overseas...

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.