FDA 510(k)

This news means that the Australian company will be able to expand to the United States. 

A new guidance from the U.S. regulator relaxes a handful of requirements for these digital health devices, and clarifies the agency's long-term enforcement policy for low-risk wellness products. 

Also: FDA clears Nuvo Group's fetal and maternal heart monitor for pregnant women; Innovaccer, Sanitas USA launch virtual COVID-19 care app.

Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces. 

The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool both employed AI to help Butterfly iQ users more easily evaluate the patient's condition. 

Also: Proof of concept for a metabolite-monitoring wristwatch; Qynapse's 510(k) clearance.

The new system lets clinicians share or capture videos and images from the OR. 

The system may now be used to target patients' internal globus pallidus, a portion of the brain associated with Parkinson's disease symptoms.

The latest platform provides developers and providers direct control over streaming health data. 

A newly published notice from the FDA suggests a new capability for the Alphabet subsidiary's clinical research wearable.