The back half of 2019 saw an FDA in the midst of a transition — both in terms of personnel and in digital regulation strategy.
On the former, the agency seems to finally be regaining its legs since the unexpected March resignation of its former head, Dr. Scott Gottlieb. After a rotating door of acting commissioners — consisting of Dr. Ned Sharpless from the National Cancer Institute and more...
This quarter was another busy one for the FDA as it continued to reevaluate its approach to digital health amidst a changing of the guard from Dr. Scott Gottlieb to its new commissioner, Dr. Norman "Ned" Sharpless.
Among its most notable digital health actions of the past few months was the agency’s decision to put out a call for new companies to try out the current framework of its Digital...
The last few months of 2018 have been fairly active for digital health regulation, with the US FDA roughly a dozen noteworthy devices and consumer health products. But the bigger news out of the agency this quarter comes in the form of its market guidance.
For instance, the very beginning of October saw the release of the Medical Device Cybersecurity Regional Incident Preparedness and Response...
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
In many ways the gatekeepers of healthcare innovation and advancement in the US, the FDA is key in shaping the future of the healthcare industry both in America and abroad. When it comes to the digital space the FDA has been evolving both in the way technology is approved and vetted.
Over the last year FDA Commissioner Scott Gottlieb has put an emphasis on speeding up the process in getting...
Brainstorming, smart design, and clinical validation are all vital steps toward the deployment of any new health technology, but without regulatory approval many of the most groundbreaking innovations will never have a chance to make an impact on patients and consumers.
In the US, these processes could see some shakeup in the future — FDA Commissioner Dr. Scott Gottlieb has been consistently...
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.
In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
The FDA has granted de novo clearance to two concussion assessment software products from ImPACT Applications. The Pittsburgh-based company developed its original software in the 90s for computers, though the clearance also includes ImPACT Pediatric, a newer version of the tests for children that runs on an iPad.
"ImPACT's FDA clearance is a huge step forward for the industry, for athletes and...
