Dave Muoio

By Dave Muoio 03:13 pmApril 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 Dave Muoio 04:22 pmApril 1, 2020
Belgium-based FibriCheck, the maker of apps that monitor a user's heart rhythm, announced yesterday that it has developed a new version of its smartwatch offering that is capable of scanning for atrial fibrillation while the wearer is asleep. FibriCheck said in a release that the updated app is currently nearing the end of user testing, and that it will be available for smartwatch manufacturers...
By Dave Muoio 02:46 pmApril 1, 2020
On Monday, Federal Communications Commission Chairman Ajit Pai pulled back the curtain on a $200 million program that would combat the COVID-19 crisis by bankrolling telecommunications equipment and services for qualifying healthcare providers. The plan is fueled by funds appropriated in the $2 trillion CARES Act signed by Congress and President Donald Trump late last week. If approved after...
By Dave Muoio 03:01 pmMarch 31, 2020
Olive, an artificial intelligence company tackling healthcare administration tasks, has closed $51 million in a funding round led by General Catalyst. Also participating in the raise were the company's existing backers Drive Capital, Oak HC/FT, Ascension Ventures and other unnamed investors. WHAT THEY DO Olive's "AI Workforce" is designed to automate a selection of tedious, high-volume...
By Dave Muoio 10:57 amMarch 31, 2020
Fitbit has announced the latest member of its fitness tracker lineup, the Fitbit Charge 4, alongside new fitness-minded features and new content for Fitbit Premium. The new device's standout feature is onboard GPS to enable features like an exercise heat map, which helps users review where in a running or biking route they were working the hardest. It returns with the Sp02 sensor of its...
By Dave Muoio 03:50 pmMarch 30, 2020
MyHeritage, a genealogy and health DNA testing company, has teamed up with the Beijing Genomics Institute (BGI) to establish a COVID-19 testing lab in its home country of Israel, the Jerusalem Post reported on Saturday. The facility is aiming to open its doors by April 9 with a 10,000-tests-per-day capacity, and hopes to scale up to 20,000 per day shortly after. “BGI will ship to Israel in the...
By Dave Muoio 04:04 pmMarch 27, 2020
Two medical research organizations have kicked off new efforts this week that seek to use consumer-health wearables to identify or event predict the onset of disease. The first is the DETECT (Digital Engagement & Tracking for Early Control & Treatment) Study, headed by the Scripps Research Translational Institute. It combines heart-rate, activity and sleep data collected through a range...
By Dave Muoio 01:55 pmMarch 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 pmMarch 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 pmMarch 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...