FDA

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. 

Bodysphere's announcement was spread across a number of mainstream news and social media channels before the company released a statement that explained its misunderstanding.

Also Cue Health scores $13 million from the department of Health and Human Services Biomedical Advanced Research and Development authority in order to fund its portable COVID-19 diagnostic test.

The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.

Dr. Yuri Maricich, chief medical officer at Pear Therapeutics, speaks on his company's experience bringing a digital therapeutic product through the regulator's experimental program for health software.

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.