FDA

The consumer-facing digital platform for health testing was forced to pump the brakes on a similar offering roughly two months ago.

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.