Regulatory/Legal
Aug 18, 2016
Antonella Carpenter In February 2016, a jury convicted Antonella Carpenter of attempting to defraud patients by claiming to cure cancer, according to a U....
Aug 16, 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 10, 2016
Here are five instances of small companies that brought patent challenges against medtech giants—but did it pay off?   Patents and technical know-how...
Jul 10, 2016
Arthrex vs Smith & Nephew It's a stretch to call Arthrex small, since the orthopedic company is one of Florida's largest private companies with...
Jul 10, 2016
RTI vs Becton Dickinson Retractable Technologies, Inc. (RTI) brought a case against medical device giant Becton Dickinson (now BD) in June 2007. The...
Jul 10, 2016
Heraeus vs Biomet Heraeus Kulzer GmbH alleged in December 2008 that Biomet, Inc. and Biomet Europe BV, and other subsidiaries misappropriated...
Jul 10, 2016
Perfect Surgical Techniques vs Olympus America Perfect Surgical Techniques brought a suit against Olympus America Inc. in November 2012, alleging...
Jul 10, 2016
Abiomed vs Maquet Cardiovascular According to an Abiomed SEC filing, Maquet Cardiovascular LLC, a Getinge Group subsidiary, sent the smaller...