FDA de novo

A green traffic light
By  Dave Muoio 03:50 pm December 8, 2020
Editor's note: This story has been updated with quotes and additional information from Mahana's CEO and cofounder. 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...
Images of the NightWare app on Apple Watches
By  Dave Muoio 02:47 pm 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...
By  Dave Muoio 09:45 am 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...
By  Dave Muoio 04:38 pm February 7, 2020
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...
By  Dave Muoio 02:13 pm December 16, 2019
The FDA announced Friday a De Novo clearance for an interoperable automated glycemic controller device for use in a hybrid closed-loop diabetes management system. Tandem Diabetes Care’s Control-IQ Technology acts as a new feature for the company’s t:slim X2 insulin pump (which was also cleared by the FDA back in February). The controller algorithm allows the pump and its connected system to...
By  Dean Koh 05:29 am July 24, 2019
Australian digital health company PainChek recently announced that the United States Patent Office has issued a Notice of Allowance for its pain assessment invention. This means that patent prosecution has been successfully completed.  The U.S. patent, when granted, gives PainChek exclusive rights to exclude others from making, using, selling or importing the invention for 20 years from the...

An illustrated graphic of how the Nerivio Migra device works. Source: Theranica

By  Dean Koh 10:40 pm May 28, 2019
Theranica, an Israel-based biomedical technology company focused on developing advanced electroceuticals for migraine and other prevalent diseases, announced on May 28 that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilising Remote Electrical Neuromodulation for the acute treatment of migraine. The FDA...
By  Dave Muoio 03:18 pm February 19, 2019
Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers. The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of...

  (Photo by Drew Angerer/Getty Images)

By  Laura Lovett 10:25 am January 8, 2019
The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model.  One of the big take aways from yesterday's announcement is that the FDA is looking to use the De Novo model to implement the next phase of the Pre-Cert pilot. The second is that the organization plans on setting up a parallel submission...
By  Jonah Comstock 04:10 pm September 13, 2018
Yesterday, Apple dropped a bombshell on the digital health world, as it is prone to do in its highly-produced launch events. While the announcement included fall detection on the Apple Watch and some improvements to heart rate monitoring, the headline was definitely the announcement that the Apple Watch Series 4 would contain an FDA-cleared ECG sensor. While much of the reaction has been positive...