Regulatory and Compliance
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 13, 2016
Marie Thibault In an update after last week's warning from FDA about ovarian cancer screening tests, Abcodia, which sells the ROCA Test, announced it is...
Sep 09, 2016
Marie Thibault Earlier detection of cancer is a good thing, right? So why did FDA just warn against ovarian cancer screening tests?  This week, the...
Sep 07, 2016
While straightforward in principle, the question of whether or not a new 510(k) is required, and what documentation is required otherwise, is one that both...
Aug 24, 2016
To decrease the possibility of failure, medical device companies must employ critical thinking, risk process point analysis, and control measures. Walt Murray...
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...