dtx

Joe Biden discussing COVID-19
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....
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 01:55 pm November 5, 2020
A recently published review of real-world claims data suggests that opioid use disorder patients prescribed Pear Therapeutics' reSET-O digital therapeutic, alongside pharmacotherapy, had fewer clinical encounters and subsequently decreased medical costs over a six-month period. The study was funded by Pear, coauthored by a Pear employee and published in the journal Expert Review of...
By  Dave Muoio 04:53 pm September 11, 2020
International pharma Boehringer Ingelheim and prescription digital therapeutics company Click Therapeutics have inked a $500 million-plus deal to jointly develop and commercialize a digital treatment for patients with schizophrenia. The treatment, referred to as CT-155, will be a mobile app built on Click's proprietary tech platform, the companies said. Employing cognitive and neurobehavioral...
By  Dave Muoio 01:40 pm August 31, 2020
Pear Therapeutics highlighted data today from two studies of a digital cognitive behavioral therapy that acted as the precursor for Somryst, the prescription digital therapeutic for adults with chronic insomnia that was the first to pass through the FDA's Pre-Cert pilot pathway. The first, a randomized controlled trial of 1,149 Australian adults with insomnia and depressive symptoms, suggested...
By  Aline Noizet 02:16 am April 29, 2020
Dr. Morcillo is the director of internal medicine Hospital Cima Sanitas in Barcelona and the medical director of Sanitas digital hospital. He is an active advocate and user of digital technologies in his daily practice. He will join the HIMSS & Health 2.0 European Digital Event (7-11 September 2020) as an expert in the session on digital therapeutics. The below Q&A has been edited for...
By  Dave Muoio 06:00 am April 22, 2020
Less than a week after FDA opened the faucet for digital health products treating psychiatric conditions during the COVID-19 health crisis, Akili has fast-tracked and released its approval-pending digital therapeutic for children with ADHD. Now known as Endeavor and flanked by a symptom tracker and caretaker support line, the video game-like app will be provided at no cost for a limited time to...
By  Dave Muoio 04:28 pm April 8, 2020
Easy access to (temporarily) free counseling. Consumer telehealth and mail-order prescription services Hims and Hers are dipping into the mental health wellness space. The brands kicked off new anonymized group therapy and guided meditation offerings yesterday, with the therapy sessions led by a licensed mental health practitioner. The group sessions are currently being offered free of charge in...
By  Dave Muoio 03:53 pm March 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 04:05 pm January 7, 2020
Editor's note: This story has been updated with additional statements from Pear Therapeutics. Pear Therapeutics pulled back the curtain this morning on a number of new deals between the prescription digital therapeutics maker and other tech companies or researchers. Ranging from virtual reality therapies to voice biomarker tech, the moves appear to be an effort from Pear to add new products to...