FDA

Eko's ECG low ejection fraction tool will now be able to help clinicians spot cardiac complications associated with the novel coronavirus. 

Users will now be able to collect a sample at home and send it to the lab in a sealed package.

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

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.