After the Food and Drug Administration relaxed guidelines last year for digital health products that treat some behavioral health conditions, startup Happify Health is making an app-based treatment for anxiety and anxiety available to patients. the Depression.
The company’s new digital therapy, called Ensemble, uses app-based exercises to help people change negative thinking patterns and develop healthy habits. It is not cleared by the FDA and is only available by prescription or through a research study. Happify plans to use real-world data to submit its product for approval in the next 18 to 24 months, wrote head of digital therapeutics Chris Wasden in an emailed statement.
New York-based Happify has already created an app that uses games and activities to help people with negative thoughts and stress. It raised $ 73 million in funding earlier this year and has partnered with multiple health plans and pharmaceutical companies.
Happify designed Ensemble using data from people who have used their app for the past eight years. People participating in the study will use the app for 10 weeks, completing two 15-30 minute exercises each day, while being guided by a chatbot. Your progress is shared with your doctor through a dashboard.
Dr. Murray Zucker, Happify’s chief medical officer, said in a press release that the activities were designed to target underlying processes that are common to both depression and anxiety. Although the app is supposed to help with symptoms, it is not intended to replace medication or therapy.
Happify is one of a multitude of mental health apps that have been available in recent years, and one of the few companies that have launched software-based treatments in the last year under new guidance from the FDA.
In April 2020, the agency decided that during the Covid-19 emergency, developers could launch “computerized behavioral therapy devices” and applications to treat psychiatric disorders without requesting 510 (k) clearance. It’s not yet clear how the companies that have made the products available will navigate it after the public health emergency is over.