FDA

By Dave Muoio 02:38 pm April 16, 2020
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency. "Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing,...
By Dave Muoio 04:28 pm April 8, 2020
Easy access to (temporarily) free counseling. Consumer telehealth and mail-order prescription services Hims and Hers are dipping into the mental health wellness space. The brands kicked off new anonymized group therapy and guided meditation offerings yesterday, with the therapy sessions led by a licensed mental health practitioner. The group sessions are currently being offered free of charge in...
By Dave Muoio 04:09 pm April 6, 2020
From me to you. Employee-wellness company Wellable has acquired assets from fellow digital-wellness product-maker MeYou Health, the companies announced. While the terms of the deal were not disclosed, it does transfer ownership of MeYou's Daily Challenge product to Wellable. This program encourages healthy eating, physical activity, stress management and other behaviors through daily email and...
By Laura Lovett 02:25 pm April 3, 2020
Earlier this week Cellex became the first company to gain an FDA Emergency Use Authorization for a serology test. The test was designed to identify specific antibodies in the blood linked to coronavirus, which means it can be used to identify past coronavirus infections.  Before this test, the products on the market were designed to detect or diagnose if someone currently has the virus. ...
By Dave Muoio 03:13 pm April 2, 2020
Editor's note: On the same day this story was published, the FDA publicized the first Emergency Use Authorization of a serology test, Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test. This story has been updated to reflect that development. On Tuesday morning, Los Angeles-based Bodysphere announced that it had received an Emergency Use Authorization (EUA) for a rapid COVID-19 serology test able to...
By Laura Lovett 04:34 pm April 1, 2020
Testing for COVID-19 has been somewhat of a roller coaster in the last few weeks. With each day, the FDA pushes forward in its efforts to expedite the review and rollout of sorely need COVID-19 diagnostic testing. It has enabled the Emergency Use Act, which relaxes standards during a time of crisis.  On March 30 the agency revealed that, since January, it has worked with more than 230 test...
By HIMSS Media 04:31 pm March 30, 2020
These have been turbulent times for the FDA. On the one hand, the U.S. regulator has found itself carefully unravelling guidances to bolster COVID-19 testing and treatment – sometimes leading to confusion for companies searching for new ways to combat the global epidemic. On the other, the agency continues to push forward with broader initiatives to remap its processes so that novel software...
By Dave Muoio 01:55 pm March 27, 2020
Yesterday, Pear Therapeutics announced the regulatory clearance of Somryst, its prescription digital therapeutic for chronic insomnia. And while the product is noteworthy for these patients and Pear's broader business, it also stands as a major milestone for the digital health industry – the first product to be evaluated throught the FDA's Digital Health Software Precertification Program. Now...
By Dave Muoio 03:53 pm March 26, 2020
Pear Therapeutics announced this morning that Somryst, its prescription digital therapeutic for adults with chronic insomnia, has received marketing authorization from the FDA. The treatment provides cognitive behavioral therapy for insomnia (CBTi) alongside personalized, algorithm-generated sleep restriction recommendations. The digital therapeutic was reviewed through the agency's 510(k)...
By Dave Muoio 03:56 pm March 25, 2020
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA. The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...