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...
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...
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...
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...
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)...
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...
Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA.
On Friday evening, the agency released an alert to consumers...
The FDA announced today a new policy that permits expanded use of connected, non-invasive remote vital sign monitors until the end of the COVID-19 public health emergency.
The agency is relaxing its prior guidance so that healthcare teams can monitor their patients outside of the hospital with certain devices that were previously cleared by the FDA, thereby freeing up space for the high volume...
The FDA is warning of new cybersecurity vulnerabilities affecting Bluetooth Low Energy communications technology used in certain medical devices. According to the agency, the issue could allow unauthorized users to wirelessly crash a device, prevent it from working or access functions limited to its users.
The FDA says the vulnerabilities – referred to as "SweynTooth" by the researchers who...
The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA announced today. Developed by Caption Health, the Caption Guidance tool guides medical professionals through a heart disease diagnostic test that normally requires an ultrasound expert.
“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and...
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