Regulatory/Legal
Aug 19, 2016
Paul Singh In March 2016, Paul Singh was sentenced to six months in prison followed by one year of home detention for defrauding patients and insurers by...
Aug 19, 2016
David Perez   In April 2016, David Perez was sentenced to 30 months in jail for selling an unapproved medical device called "Energy Wave" online and...
Aug 19, 2016
Pharmaceutical Innovations Inc. In July 2016, Pharmaceutical Innovations Inc. of Newark, NJ, pleaded guilty to criminal charges around its distribution of...
Aug 19, 2016
Occasionally, medical devices are tools for criminal acts. Here are five astonishing medical device-related crimes. When medical devices get mixed up in...
Aug 17, 2016
Tips and tricks for medical device manufacturers to ensure they meet the upcoming UDI deadline. Steve Cottrell and Madris Tomes The American Hospital...
Aug 10, 2016
CDRH is developing guidance that prioritizes making life easier for industry. It's part of a changing mindset at the agency under the industry-friendly...
Jul 20, 2016
A novel trial design shares patient samples and takes a "universal analysis" approach to accelerate sepsis assays to FDA clearance. Marie Thibault Two sepsis...
Jul 11, 2016
Abiomed vs Maquet Cardiovascular According to an Abiomed SEC filing, Maquet Cardiovascular LLC, a Getinge Group subsidiary, sent the smaller...
Jul 11, 2016
Perfect Surgical Techniques vs Olympus America Perfect Surgical Techniques brought a suit against Olympus America Inc. in November 2012, alleging...
Jul 11, 2016
Heraeus vs Biomet Heraeus Kulzer GmbH alleged in December 2008 that Biomet, Inc. and Biomet Europe BV, and other subsidiaries misappropriated...