FDA de novo clearance

By Dave Muoio February 14, 2018
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 Jonah Comstock September 14, 2017
In an FDA first, Boston- and San Francisco-based Pear Therapeutics' reSET system for the treatment of substance abuse has been granted a de novo clearance by the agency. It's the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease. “This is a defining moment for digital therapeutics and for patients with substance use disorder,” Corey...
By Jonah Comstock July 6, 2015
According to an SEC filing, mail-order personal genome service and research company 23andMe has raised $79 million, in a round the company hopes will top out at $150 million. The investors are undisclosed and 23andMe declined to comment while the round was ongoing. This is the company's largest single funding raise to date. It brings its total funding to $190 million plus a $1.4 million research...