Regulatory/Legal
Sep 28, 2016
Seven major private payers and health technology assessment groups have raised their hand to give interested medical device companies early feedback on...
Sep 23, 2016
FDA gave the medtech industry draft guidance on additive manufacturing earlier this year, but how can manufacturers translate the agency's thoughts into their...
Sep 16, 2016
FDA has made it clear that manufacturers truly can use adaptive design in medical device trials. An expert shares the benefits of adaptive design and offers...
Sep 15, 2016
A group petitions FDA for an overhaul of the agency's approach to medical products. Will FDA be able to transform itself? Jim Dickinson FDA is not known for...
Sep 15, 2016
Changes to the U.S. patent system over the past several years are hurting the medical device industry. Eb Bright For generations here in the United States,...
Aug 25, 2016
What should a startup in either the medical or wellness wearable device space be doing about IP? Gerard von Hoffmann and Bryan Wahl We are exploding into a...
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...