Regulation

FDA
By Laura Lovett 02:25 pm November 23, 2020
Cardio-focused digital health company AliveCor landed FDA clearance for its new suite of interpretive ECG algorithms, dubbed the Kardia AI V2. This news comes just days after the company announced a $65 million Series E funding round. The new clearance will is able to capture sinus rhythm with premature ventricular contractions, sinus rhythm with supraventricular ectopy and a sinus rhythm with...
The Lucira COVID-19 All-in-One Test Kit and its packaging
By Dave Muoio 12:29 pm November 18, 2020
Yesterday afternoon, the U.S. FDA issued an Emergency Use Authorization (EUA) to a COVID-19 molecular diagnostic test that provides individuals with a result within 30 minutes, in the comfort of their home. As opposed to currently available at-home testing products, which have patients self-collect a nasal swab sample and ship it for processing in a lab, the Lucira COVID-19 All-in-One Test Kit...
Joe Biden discussing COVID-19

 (Photo by Joshua Roberts/Getty Images)

By Laura Lovett 12:01 pm November 10, 2020
Now that the election has been called in favor of now President-elect Joe Biden, the medical community has poured out offering congratulations, suggestions and predictions. The bulk of the organizations are towing a nonpartisan line, pledging to work with the new administration, but remaining shy of political backing.  Innovation  One such organization is the American Telemedicine Association....
By Dave Muoio 12:28 pm October 21, 2020
The past couple of days have seen a handful of artificial intelligence algorithms for radiology imaging analysis receive 510(k) clearances from the FDA. Two of these, from Quantib and Ezra, are focused on the relatively untouched area of prostate cancer screening, while a third, from Aidoc, targets incidental pulmonary embolism. Quantib's software delivers an in-workflow assessment of prostate...
By Laura Lovett 12:10 pm October 21, 2020
Virtual reality company AppliedVR has landed an FDA Breakthrough Device designation for its technology designed to treat fibromyalgia and chronic lower back pain. The tool, named EaseVRx, combines a VR headset with visual and audio programs that deliver cognitive behavioral therapy (CBT), relaxation, and mindfulness training, as well as other behavioral methods to give what it calls “self-...
By Dave Muoio 03:09 pm October 12, 2020
As healthcare becomes more digitized and clinical treatments shift away from one-size-fits-all therapies, the industry will need to become more critical about how it's employing and curating health data. For vendors and providers, it's about understanding what tools are at their disposal and how they can be implemented to maintain and improve the standard of care. But for regulators like the FDA...
By MobiHealthNews 11:42 am October 9, 2020
With its recent launch of the Digital Health Center for Excellence, the FDA has shown a new spotlight on its ongoing work of changing how the regulation of digital health and digital therapeutics works, to better match the realities of modern technology. But is the organization taking the right steps for the right reasons? Or is it heading into dangerous territory for developers and their end...
By Dave Muoio 03:05 pm October 6, 2020
The FDA has issued an Emergency Use Authorization (EUA) to a clinical decision support (CDS) tool that predicts when an adult patient admitted to the hospital with COVID-19 is at risk of further complications. Developed by Oakland, California-based diagnostic algorithm developer Dascena, the COViage Hemodynamic Instability and Respiratory Decompensation Prediction System reviews demographic and...
By Dave Muoio 04:00 pm September 22, 2020
The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the agency as well as external stakeholders promote digital health technologies. Housed within the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence (DHCE) will focus on a range of technologies "mobile health devices, Software as a Medical...
By Laura Lovett 03:16 pm September 17, 2020
For digital therapeutics companies, the FDA has often been viewed as the gatekeeper to getting products to the patients. However, today the conversation around efficacy and research is branching beyond just what ticks the FDA boxes, into what kinds of studies are needed to meet the expectations of stakeholders and end users. This morning at DTx East, a group of panelist discussed the current...