FDA Finalizes Guidance on Clinical Decision Support (CDS) software as a medical device: Developers take note – FDA issues clinical decision support software FINAL GUIDANCE

Final FDA guidance on regulating Clinical Decision Support (CDS) software as a medical device deviates from draft guidance issued in 2019.  CDS software that is designed to acquire or analyze medical images or signals from diagnostic devices may be subject to regulation as a device; however, software designed for other purposes that meets three other criteria may be exempt.

Inspector General finds FDA’s early COVID diagnostic policies came at a ‘cost to test quality’

As the U.S. gatekeeper for medical tests, how should the FDA strike a balance between making sure the public has options during a national emergency and making sure those tests actually work?  The Agency’s stumbles during the earliest stages of the COVID-19 pandemic hold some important lessons, according to a report from the inspector general of the Department of Health and Human Services (HHS).

At home blood pressure monitoring shows promise: Smartphone cameras could replace pulse oximeters to measure blood oxygen at home a study shows

Over the course of the last decade or so, smartphones have slowly morphed into full-fledged medical tools.  Mobile devices are now being used to read diagnostic test results, scan photos taken by their built-in cameras to spot signs of disease and even to take the place of pulse oximeters in measuring blood oxygen levels.