digital diagnostic

Three screens of the Ellume COVID-19 Home Test App

First OTC, app-connected COVID-19 test authorized by FDA

By Dave Muoio 03:13 pm December 15, 2020

The U.S. FDA announced today an Emergency Use Authorization for the first over-the-counter COVID-19 diagnostic test for home use. Developed by Australian digital diagnostics company Ellume Health, the single-use kit is accompanied by a Bluetooth-connected app that guides users through the testing process and automatically reports its results for disease monitoring. The test returns its results in...

Cognoa targets De Novo authorization for its autism diagnostic after reporting strong pivotal study results

By Dave Muoio 09:45 am September 23, 2020

Cognoa, a digital health company developing software tools for children with autism and other behavioral health conditions and their families, signaled today that it will be moving ahead with a De Novo FDA regulatory submission for its digital autism spectrum disorder (ASD) diagnostic. The tool, which received a Breakthrough Device Designation from the agency in late 2018, is designed to help...