December 4, 2020
The FDA has granted a De Novo clearance to San Francisco-based Mahana Therapeutics' Parallel, a prescription digital therapeutic for patients with irritable bowel syndrome (IBS) that delivers cognitive behavioral therapy (CBT).
The agency made its decision on November 25, according to an FDA listing updated on Monday. Mahana submitted the application back in April.
Per the company's website,...
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...
November 9, 2020
The FDA granted Minneapolis-based NightWare a De Novo clearance on Friday for its Apple Watch and iPhone app designed to improve the sleep quality of those experiencing nightmare disorder and nightmares related to PTSD.
The digital therapeutic – which received breakthrough designation from the agency last year – uses the Watch's sensors to track the heart rate and movement of users as they sleep...
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...
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...
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...
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...
September 23, 2020
Cognoa, a digital health company developing software tools for children with autism and other behavioral health conditions and their families, signaled today that it will be moving ahead with a De Novo FDA regulatory submission for its digital autism spectrum disorder (ASD) diagnostic.
The tool, which received a Breakthrough Device Designation from the agency in late 2018, is designed to help...
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...
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...