Regulation

The latest on COVID-19 testing: FDA updates; Ready Responders land $48M to administer COVID-19 tests at home
By Laura Lovett | 05:34 pm | April 01, 2020
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.
HIMSSCast: FDA grapples with home COVID-19 testing, moves forward with Pre-Cert Program
By HIMSS Media | 05:31 pm | March 30, 2020
The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.
Q&A: A firsthand account of FDA's Pre-Cert Program
By Dave Muoio | 02:55 pm | March 27, 2020
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.
FDA clears Pear's digital insomnia therapeutic through 510(k), Pre-Cert pilot pathways
By Dave Muoio | 04:53 pm | March 26, 2020
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. 
Butterfly rescinds features from handheld ultrasound device, working with FDA to re-enable
By Dave Muoio | 04:56 pm | March 25, 2020
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. 
At-home COVID-19 testing services pump the brakes after FDA warns of 'fraudulent' kits
By Dave Muoio | 05:32 pm | March 23, 2020
Nurx, Carbon Health and Everlywell have officially halted their mail-order testing-kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.
FDA expands use of vital sign monitors to enable remote care, modifications during COVID-19 emergency
By Dave Muoio | 05:50 pm | March 20, 2020
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
Proov gets FDA nod for its at-home ovulation testing kit
By Laura Lovett | 05:07 pm | March 11, 2020
The company plans to roll out a corresponding app this Spring.   
UK government sets up unit to tackle disinformation linked to coronavirus
By Leontina Postelnicu | 08:48 am | March 09, 2020
Experts will work with social media giants to curb the spread of misleading and deceiving claims.
US senators question Ascension on its Google collaboration Project Nightingale
By Laura Lovett | 03:09 pm | March 04, 2020
Elizabeth Warren (D-MA), Richard Blumenthal (D-CT) and Dr. Bill Cassidy (R-LA) sent a follow-up letter to Ascension CEO Joesph Impicciche regarding privacy concerns about Project Nightingale.