Dive Brief:
- The Food and Drug Administration has picked two behavioral health companies to join its Technology-Enabled Meaningful Patient Outcomes, or TEMPO pilot, growing the total number of participants to four.
- Limbic and Sondermind are the next companies to join the pilot program, which allows participants to gather real-world data on devices while being exempted from premarket authorization requirements.
- Amid the pilot program, the FDA has also held discussions on digital health technologies for mental health, with patient groups calling for broader oversight in the use of generative artificial intelligence.
Dive Insight:
London-based Limbic will offer an AI mental health service called Unpacked as part of the program. The service provides cognitive behavioral therapy for people with anxiety or depression through telephone calls with an AI voice agent, overseen by a clinician. Limbic CEO Ross Harper said in a statement that the service is intended to address the shortage of mental health professionals.
The program is contraindicated for several conditions and is also limited to people who speak English and have access to a telephone.
Denver-based Sondermind plans to offer a smartphone application to help reduce anxiety and depression in adults, as an adjunct to therapy or medication. The device, called the SonderMind Adjunctive Care Application, is contraindicated for people experiencing suicidality, manic episodes, psychosis and PTSD.
Both selected companies will be able to offer their devices through a new Medicare payment model that rewards providers for improving patient outcomes. The program is designed to support the use of technology to manage chronic health conditions.
The FDA has chosen a total of four participants for the TEMPO program, including diabetes technology firm Dexcom and Cadence, a company making a tool for hypertension management.
