FDA

The continuous remote monitor can help prevent complications driven by experimental COVID-19 treatments such as hydroxychloroquine or chloroquine, according to the agency.

Also: HHS awards $20 million in telehealth access, infrastructure funds; Lumi launches online service.

The new tool will be released for limited distribution and will provide multimodal neurobehavioral interventions. 

Epstein Becker & Green's Bradley Merrill Thompson describes the agency's current trajectory for regulation of patient-facing and provider-facing telehealth products that incorporate AI.

In response to recent COVID-19 guidance, the company is releasing its video game-like treatment to qualifying families at no cost, and without explicitly requiring a doctor's prescription.

Using a designated kit ordered by a doctor, patients will be able to self-swab and mail their samples to LabCorp testing facilities. The self-collection kits will be available in "most states" in the coming weeks.

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 COVID-19 policy allows for remote use, digital modifications to ophthalmic devices; 23andMe launches genetics study to understand varying COVID-19 responses.

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

The test was designed to identify specific antibodies in order to detect if a patient has had coronavirus in the past.