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.
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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.
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
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.
At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.
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.