FDA

Biobeat's connected remote monitoring device is currently available as either a wristwatch or an adhesive patch.

Researchers analysed key characteristics of over 600,000 menstrual cycles and data from nearly 125,000 women from Sweden, the UK and the US using the Natural Cycles app.

According to the recall document, the company didn't have FDA authorization to market the product. 

Oleena's algorithms serve patients personalized guidance on how best to mitigate symptoms, while also monitoring and generating insights for their care team.

The company's latest algorithm extracts raw data from a variety of sensors and unifies them into a uniform vital signs reading, MobiHealthNews exclusively learned.

Also: Liva Healthcare inks deal with Care City; SnapMD teams up with Carefluence on new platform. 

The organization reports it has completed retrospective testing and is in the process of prospective testing. 

CEO and President Dr. Corey McCann said that Somryst, a digital treatment for chronic insomnia and depression, is the first software as a medical device product to be submitted through the regulator's pilot pathway. 

The agency also warned consumers of unregulated diabetes products and outlined plans for AI device regulation.

The suit alleges that only three of the nine STD tests sold by WebMD have undergone FDA approval process.