Regulatory/Legal
Oct 17, 2016
A recent report from the Medical Device Innovation Consortium (MDIC) takes a small step toward a system that would ease FDA's burden by encouraging aggressive...
Oct 17, 2016
Learn what it takes to obtain the ISO 17025 laboratory accreditation from professionals who recently completed the process. Gaetano (Tom) Rizzo, Donna Ventura...
Oct 06, 2016
Digital medicine is expected to play a major role in the future of healthcare, but stakeholders still need to iron out the wrinkles. This is the state of...
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FDA gave the medtech industry draft guidance on additive manufacturing earlier this year, but how can manufacturers translate the agency's thoughts into their...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....