The FDA announced yesterday that it will permit marketing of Viz.ai’s Contact, a clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke.
The CDS application was submitted through the agency’s de novo premarket review pathway, and as such creates a new regulatory classification for similar AI-drived platforms to come. The FDA’s...
By Bradley Merrill Thompson
Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps. Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well...
A little more than a month ago, Naomi Fried, chief innovation officer at Boston Children's Hospital, tweeted: that most healthcare mobile apps are built for consumers and focus on health and wellness, while only 20 percent are clinical apps. She wrote: "We need more #hospital apps." Naturally, this caught our attention.
"There's a huge opportunity for mobile apps in the hospital environment,"...
