Regulatory and Compliance
Aug 23, 2016
Marie Thibault ImPACT and ImPACT Pediatric have been FDA-cleared for use in assessing a person's cognitive function after a suspected concussion or brain...
Aug 19, 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 19, 2016
Vinnie Lysander Taylor In May 2016, Vinnie Lysander Taylor pleaded guilty to charges of "receiving and selling industrial grade silicone, but representing...
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
An expert shares four things he's learned about the 510(k) submission process that you can use to your advantage. Jon Speer As you are probably aware, a 510(k...
Aug 11, 2016
Marie Thibault After much deliberation and years of waiting, FDA this week released two draft guidances on when a modification warrants a new 510(k)...
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...