The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.
Pear Therapeutics’ Chapter 11 bankruptcy filing follows three corporate restructurings and the inability to secure additional financing to support commercialization of its FDA-cleared prescription digital therapeutics. An auction of Pear’s assets is expected to happen in early May.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Pear Therapeutics is implementing a corporate restructuring projected to save about $28 million. The goal is to extend its available cash as the company presses on with commercialization efforts for its digital therapeutics.
Biogen struck a deal that could bring a digital therapeutic to its multiple sclerosis product portfolio. The drugmaker is partnering with startup MedRhythms in the development of a therapy that combines sensors, software, and music to improve walking problems in multiple sclerosis patients.
MetaMe received FDA clearance for its first digital therapeutic on Tuesday. It uses behavioral therapy to help alleviate abdominal pain symptoms for patients with irritable bowel syndrome.
The company is developing a digital therapeutic using VR to manage chronic lower back pain. It recently submitted an application for de novo clearance to the FDA.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Happify is making its app-based treatment available to patients thanks to a loosened FDA guidance last year that lets digital health companies targeting some behavioral health conditions release their product without clearance. The company is launching an investigational study to get data for a future FDA submission.
Renovia, a digital health startup that developed an app-based program for urinary incontinence, raised $17 million in funding. The company recently completed a clinical trial that it plans to share with insurance carriers as evidence of its efficacy.
SoftBank’s second Vision Fund led the recent funding round. Pear plans to use it to accelerate reimbursement coverage for its three FDA-cleared products.
Judges picked Atentiv as the winning pitch at MedCity Invest’s virtual conference. The Boston-based startup is building a game to improve attention in kids with ADHD.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Digital health company Akili Interactive received FDA de novo clearance for its digital therapeutic, a video game intended to improve attention among kids with ADHD.