FDA

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. 

The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool both employed AI to help Butterfly iQ users more easily evaluate the patient's condition.