Regulatory/Legal
Aug 17, 2015
Michael Stanley Kaplan In May 2015, Michael Stanley Kaplan, a urologist in Las Vegas, was sentenced to four years in prison for reusing single-use needle...
Aug 17, 2015
Dipak Desai In July 2015, Dipak Desai, former owner of the Endoscopy Center of Southern Nevada, was sentenced to 71 months in prison by federal...
Aug 14, 2015
Occasionally, the medtech industry is the setting for illegal behavior. Here are 10 medical device-related crimes that landed perpetrators in jail....
Aug 14, 2015
Charlie Chi In June 2015, Charlie Chi, who was formerly CEO of OtisMed Corporation, was sentenced to two years in prison. His crime? Distributing the...
Aug 14, 2015
Tonya Rushing In May 2015, Tonya Rushing, former CEO of Endoscopy Center of Southern Nevada, was sentenced to one year and one day in prison. According to...
Aug 14, 2015
It's your turn. If you've had interactions with FDA, we want to hear how you'd grade the regulator. We asked regulatory experts to tell us how they think FDA...
Aug 12, 2015
New research from Harvard Business School finds first mover devices have a regulatory disadvantage at FDA, making it particularly hard for small firms to be...
Aug 07, 2015
Last month, senators proposed a bill to reform FDA's combination product regulations, but experts don't agree on the details of the legislation. Marie Thibault...
Aug 03, 2015
FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam. Jim Dickinson FDA has long glowed...
Jul 28, 2015
An FDA official gives a concrete example of how the agency decided that clinical trials without a control arm could be used to assess a certain type of device...