Decentralized digital therapeutic trial. Pear Therapeutics has enrolled the first participant in the DREAM study, an open-label trial of its Somryst prescription digital therapeutic for chronic insomnia.
Conducted as a decentralized trial, the effort will recruit U.S. adults aged 22 to 75 years who have an Insomnia Severity Index score of 8 or higher, as well as at least three months of insomnia...
Digital therapeutics company Pear Therapeutics has inked a deal with pharmacy benefits manager (PBM) RemedyOne, allowing the latter to offer and administer benefit coverage for the formers’ prescription-addiction-focused therapies reSET and reSET-O to its customers.
Both reSET and reSET-O have FDA clearances. In fact, reSET was the first software-only therapeutic to get the designation. reSET ...
The healthcare startup market has always had the unique challenge of selling its innovations almost exclusively to major businesses. Although recent years have seen a rise in digital health offerings focused on patient satisfaction, if not on selling their product directly to the consumer, the reality of the industry is that insurers, pharmacy benefit managers, large employers, health systems,...
Pear Therapeutics is rolling out its new digital therapeutic aimed at treating schizophrenia for limited distribution, after the FDA loosened up its regulations for digital psychiatric disorders devices during the coronavirus crisis.
The new tool, called Pear-004, uses multimodal neurobehavioral interventions combined with antipsychotic medications. Patients with schizophrenia can use the tool...
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...
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)...
Digital chronic care management company Livongo and health kiosk startup Higi have teamed up for a new program that will bring a Livongo-branded on-stage program to nearly 500 retail pharmacies in Michigan, the companies announced today. Through these and other channels, consumers will be able to measure indicators of chronic disease, enroll in Livongo programs, participate in health surveys and...
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...
It has been a tumultuous week in the realm of digital health partnerships. It started with word of Proteus Digital Health’s floundering business and failed investment round, which reports say was partially driven by cooling relations between the digital pill maker and its longtime patron Otsuka Pharmaceuticals. A few days later, Sanofi announced a company-wide strategy shift that found Onduo, its...
Pear Therapeutics has announced a new deal with Ironwood Pharmaceuticals that will explore the platform’s potential for patients with certain gastrointestinal (GI) conditions.
“We are excited to be partnering with Ironwood on this initiative and believe there is a compelling clinical rationale for use of [prescription digital therapeutics] in treating GI diseases,” Dr. Corey McCann, president and...
