Licensed Psychiatrist

FDA adds two behavioral health firms to TEMPO pilot. Sondermind and Limbic are evaluating digital health devices intended to help with anxiety and depression. Published Aug. 24, 2026 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.

SonderMind launches Suite of clinically-backed AI tools for mental health care delivery to help people feel better, faster. Grounded in Privacy and Clinician Oversight, SonderMind's AI Suite Provides Continuous Care Beyond the Therapy Session DENVER-(BUSINESS WIRE)-SonderMind, a leader in enabling a continuous care journey beyond the therapy session, today unveiled the SonderMind AI Suite of clinically-backed features that leverage the power of AI and convenience of the SonderMind app to save providers time, empower the client-provider relationship, and provide support in the moments between sessions. Built with clinician oversight, the SonderMind AI Suite is governed ethically by SonderMind's AI Constitution. "AI is all around us, including in mental health care, but AI cannot replace the human connection that is absolutely necessary to move the needle for individuals in need," said Mark Frank, Chief Executive Officer and Co-Founder of SonderMind. "At SonderMind, we are laser focused on developing AI-powered tools, built with rigorous clinical oversight, that improve and complement the core principle of therapy - human connection." For health systems and payors seeking measurable, scalable behavioral health solutions that lower total cost of care, and deliver continuity across the member journey, SonderMind's AI Suite improves engagement, accelerates provider documentation, and reinforces client progress between visits. Unlike fragmented point solutions, SonderMind delivers accountable mental health care, powered by ethical AI and built for value-based health care. * Increased impact of care: Deepens therapy impact and speed to outcomes. * Measurable outcomes built for value-based care: Claim turnaround time, measured goal attainment mapped to value-based healthcare, with tools and reporting aligned to VBHC contracts and quality measures. * Clinically-backed, ethically governed: Always co-developed with clinicians, never autonomous. For those in therapy, the hardest part might not be the one-hour session, but the 167 hours of the week between sessions. SonderMind's AI Suite fills this gap, giving clients a 24/7 clinical companion to reinforce insights, track progress, and provide motivation, beyond the typical weekly or recurring session. * Continuous, personalized care accessible at scale: Always-on support extends the impact of therapy with recaps, journaling, and goal-setting. * Clinical & ethically rigorous AI with unmatched privacy: HIPAA-compliant, encrypted tools developed with licensed clinicians and strict governance. SonderMind's AI capabilities streamline clinician workflows - helping reclaim time, reduce burnout, and enable providers to be more present when engaging with clients. Integrating SonderMind's AI capabilities across the ecosystem ensures that traditional silos are eliminated and enables greater human connection and engagement. * Huge time-savings: AI Notes, Session Prep, Treatment Plans, and Session Takeaways reduce administrative work without compromising quality. * Strengthened therapeutic alliance: Increased provider presence to reinforce - not replace - the relationship between a therapist and their client. * Ethically governed, practice-grounded: HIPAA-compliant, co-developed with licensed clinicians, guided by SonderMind's AI Constitution. * Seamless support that providers control: Integrated directly into a provider's workflow, all AI-enhanced features are 100% opt-in with no extra steps. SonderMind's generative AI features are governed by SonderMind's AI Constitution - a clinical, privacy-first framework that guides development, deployment, and oversight, and approved by SonderMind's AI Governance Council comprised of clinicians, compliance experts, and product leaders. * Clinician-guided: Co-developed with licensed therapists; released only after clinical review and workflow testing. * Client control: Explicit opt-in for recording; easy opt-out from covered features; providers retain control over provider features. * Privacy & security: HIPAA + ISO 27001; dual encryption; encrypted audio deleted after 30 days; feature-specific deletion protocols. * Accountable governance: Cross-functional AI Governance Council; documented intended use/risks; annual bias & safety reviews; audit logs. SonderMind's commitment to safe AI usage and compliance is evident in its adherence to HIPAA and ISO 27001 standards, dual encryption, and privacy-by-design principles. About SonderMind At SonderMind, we believe everyone deserves to have continuous mental health care 24/7, at any stage of life. SonderMind care encompasses everything from therapy and medication management to meditation and mindfulness exercises. Our clinicians leverage our digital tools and research to deliver increasingly high-quality care and to develop thriving practices. Combining technology and human connection, SonderMind drives better outcomes through our comprehensive approach. Learn more about SonderMind at sondermind.com or download the mobile app, available on iOS and Android.