Cognoa's AI platform for autism diagnosis gets first FDA stamp

Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism -- meaning the digital health startup is now positioned to submit an application for full FDA clearance. It's a first but important regulatory step for a business that was founded back in 2014, and plays in a still nascent digital health space where untested'wellness' apps are far more plentiful than medical technologies with robust data to prove out the efficacy of their interventions. Discussions with the FDA started in early 2017, says Cognoa CEO Brent Vaughan, adding that it's hoping to gain full FDA clearance this year. He says the ultimate goal for the US startup is to become a standard part of domestic health insurance-covered medical provision -- and for that FDA clearance is essential to opening the doors. We first covered the Cognoa at launch in 2014 and the following year when it was still being careful to describe its technology as a screening rather than a diagnostic system.