What are the most promising investment opportunities in FDA-approved digital therapeutics?

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Digital therapeutics represent a revolutionary healthcare category where software itself becomes the medicine, backed by rigorous clinical trials and FDA approval.

Unlike general wellness apps or telehealth platforms, these evidence-based interventions are prescribed by doctors to treat specific medical conditions, creating a new asset class for investors and entrepreneurs seeking to capitalize on the intersection of technology and healthcare.

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What exactly are digital therapeutics and how do they differ from general wellness apps or telehealth platforms?

Digital therapeutics are FDA-regulated software-only medical devices that deliver evidence-based therapeutic interventions to prevent, manage, or treat medical conditions through prescribed clinical protocols.

The fundamental distinction lies in regulatory oversight and clinical validation. Digital therapeutics must demonstrate clinical efficacy through randomized controlled trials and obtain FDA clearance (510(k) or De Novo pathway), whereas general wellness apps provide self-tracking or lifestyle coaching without FDA oversight or prescription requirements. Telehealth platforms enable remote healthcare service delivery but do not themselves deliver therapeutic interventions with proven efficacy.

This regulatory framework means digital therapeutics carry therapeutic claims backed by rigorous clinical evidence, allowing physicians to prescribe them as medical treatments. For example, Pear Therapeutics' reSET requires a prescription and has demonstrated statistically significant improvements in substance abuse treatment outcomes, while a general wellness app might simply track sobriety days without clinical validation.

The prescription requirement creates distinct market dynamics, as digital therapeutics must navigate traditional healthcare sales cycles, payer reimbursement, and clinical adoption pathways rather than direct-to-consumer app store distribution models.

Which digital therapeutics have already received FDA approval, and what specific conditions or disorders do they target?

Thirteen prescription digital therapeutics have received FDA clearance as of July 2025, targeting diverse therapeutic areas from mental health to metabolic disorders.

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What are the main categories within FDA-approved digital therapeutics, and which therapeutic areas show the most commercial promise?

FDA-approved digital therapeutics cluster into three primary therapeutic categories, with behavioral and mental health applications demonstrating the strongest commercial traction and reimbursement success.

Behavioral and Mental Health represents the largest category with seven products targeting depression, anxiety, insomnia, and substance use disorders. This segment shows the strongest commercial promise due to high unmet medical need, established cognitive behavioral therapy evidence base, and existing Medicare reimbursement codes (G0552-G0554) that enable billing for digital mental health devices and provider management time.

Neurological and Cognitive applications include two products addressing ADHD attention function and migraine prevention. This emerging category benefits from quantifiable clinical endpoints and growing acceptance of digital neuromodulation approaches, particularly in pediatric populations where traditional pharmaceutical options may be limited.

Metabolic and Gastrointestinal disorders encompass four products targeting type 2 diabetes, irritable bowel syndrome, and fibromyalgia pain management. This category presents significant growth potential as healthcare systems shift toward value-based care models that emphasize chronic disease management and patient self-efficacy.

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Which companies or startups are currently leading the market in FDA-approved digital therapeutics, and what are their core products?

Eight companies currently dominate the FDA-approved digital therapeutics landscape, with Pear Therapeutics and Big Health establishing the strongest product portfolios and market presence.

Pear Therapeutics leads with three FDA-cleared products spanning substance use disorders and sleep medicine. Their reSET platform for substance abuse treatment generated significant real-world evidence demonstrating improved treatment retention rates, while Somryst for chronic insomnia has established partnerships with major health systems including Kaiser Permanente and Cleveland Clinic.

Big Health operates two complementary platforms addressing anxiety and sleep disorders. DaylightRx for generalized anxiety disorder and SleepioRx for chronic insomnia leverage the company's established cognitive behavioral therapy digital delivery expertise, supported by over 40 peer-reviewed publications demonstrating clinical efficacy.

Click Therapeutics focuses on neurological and psychiatric applications with CT-132 for migraine prevention and Rejoyn for major depressive disorder. The company raised $48.5 million in Series C funding in March 2025, led by Dassault Systèmes, signaling strong investor confidence in their neuroscience-focused approach.

Akili Interactive operates the only FDA-cleared digital therapeutic specifically targeting pediatric populations with EndeavorRx for ADHD attention function improvement. Their game-based intervention approach represents a unique therapeutic modality that has attracted partnerships with pharmaceutical companies including Shire (now Takeda).

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What specific problems are these companies aiming to disrupt in the healthcare system or pharmaceutical industry?

Digital therapeutics companies target fundamental healthcare access and efficacy gaps that traditional pharmaceutical and care delivery models struggle to address at scale.

Limited access to cognitive behavioral therapy represents the primary disruption opportunity, as fewer than 3% of Americans with mental health conditions receive evidence-based psychotherapy due to provider shortages and geographic barriers. Companies like Big Health and Pear Therapeutics deliver standardized CBT protocols that can reach patients regardless of location or provider availability, potentially addressing the 120 million Americans living in mental health professional shortage areas.

Medication adherence and treatment engagement challenges create significant cost burdens, with non-adherence contributing to approximately $100 billion in annual healthcare costs. Digital therapeutics platforms provide continuous patient engagement mechanisms, behavioral reinforcement, and real-time monitoring capabilities that traditional pharmaceutical approaches cannot match.

Chronic disease self-management inefficiencies represent another major disruption target, particularly in metabolic disorders where lifestyle interventions prove more effective than medications alone for many patients. Better Therapeutics' AspyreRx for type 2 diabetes management aims to reduce healthcare utilization by empowering patients with evidence-based behavior change tools that complement traditional pharmacotherapy.

The scalability limitations of traditional psychotherapy create market opportunities for companies like Click Therapeutics, whose platforms can deliver personalized therapeutic interventions to thousands of patients simultaneously while maintaining clinical efficacy standards that match or exceed in-person therapy outcomes.

Can individual investors or venture firms currently invest in these companies, and what are the typical entry requirements or channels?

Investment access varies significantly across digital therapeutics companies, with public market options providing immediate liquidity while private opportunities require accredited investor status and higher minimum commitments.

Public companies offer direct equity access through traditional brokerage accounts. Pear Therapeutics trades on NASDAQ under PRTS, Big Health on NYSE as BH, and Teladoc Health (which acquired Livongo's digital therapeutics assets) on NYSE as TDOC. These positions provide immediate liquidity and transparency but may carry higher valuations due to public market premiums.

Private startup investments typically require accredited investor status ($1 million net worth or $200,000 annual income) and minimum commitments ranging from $100,000 to $1 million depending on the funding round stage. Venture capital rounds from Seed to Series C provide primary investment opportunities, while secondary share platforms like Forge and EquityZen enable purchases of existing employee or early investor stakes.

Strategic corporate partnerships offer alternative access channels, including corporate venture capital arms from pharmaceutical companies, health insurers, and technology giants. These relationships often provide preferred access to late-stage rounds and acquisition opportunities before they reach broader investor markets.

Specialized healthcare funds and digital health syndicates provide institutional-quality deal flow and due diligence for individual investors seeking exposure without direct company selection responsibilities. Notable funds focusing on digital therapeutics include Healthtech Capital, 7wire Ventures, and GV (Google Ventures) healthcare portfolio.

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Which startups in this space are still private but might be approaching IPO or acquisition, and how can someone position early for those opportunities?

Several private digital therapeutics companies with FDA clearances or Breakthrough Device designations appear positioned for potential exits within 12-18 months based on funding milestones and market traction indicators.

• Cognito Therapeutics: Developing neuromodulation digital therapeutics for Alzheimer's disease with FDA Breakthrough Device designation. The company's gamma wave stimulation approach addresses a $321 billion market with limited treatment options, making it attractive for pharmaceutical company acquisition or strategic partnership.
• MedRhythms: Focus on gait rehabilitation through digital therapeutics with FDA Breakthrough Device status for stroke recovery applications. Their neurologic music therapy platform targets the $4.8 billion neurological rehabilitation market.
• MindMaze: Virtual reality-based neurorehabilitation platform with FDA clearance for upper limb motor function recovery. The company has raised over $125 million and established partnerships with major health systems.
• NightWare: Wearable digital therapeutic for PTSD-related nightmares with FDA clearance. Their smartwatch-based intervention targets the veteran and trauma survivor populations with quantifiable sleep improvement outcomes.

Early positioning strategies include participating in late-stage venture rounds, engaging with industry accelerators like the Digital Therapeutics Alliance, building strategic pilot partnerships with health systems or payers, and monitoring SEC filings for S-1 registration statements indicating IPO preparation.

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What have been the major funding rounds, mergers, or acquisitions in digital therapeutics so far in 2025?

2025 has witnessed significant capital deployment and strategic consolidation in digital therapeutics, with total funding exceeding $400 million across major rounds and strategic partnerships.

Click Therapeutics secured $48.5 million in Series C funding led by Dassault Systèmes in March 2025, representing the largest venture round in the sector this year. The funding supports their CT-132 migraine prevention platform commercialization and Rejoyn depression treatment market expansion, signaling strong investor confidence in neuroscience-focused digital therapeutics.

Sidekick Health raised €35 million in venture debt from the European Investment Bank in May 2025, focusing on chronic disease management applications across European markets. This debt financing structure reflects the company's revenue-generating status and provides growth capital without equity dilution.

Flo Health achieved unicorn status with a $200 million Series C in late 2024 extending into early 2025, though their reproductive health focus represents adjacent rather than core digital therapeutics applications. The round demonstrates investor appetite for regulated health applications with consumer-facing distribution models.

Strategic pharmaceutical partnerships have intensified, with Otsuka investing over $300 million in Rejoyn depression treatment development and Boehringer Ingelheim committing $500 million toward schizophrenia digital therapeutics applications. These partnerships validate pharmaceutical industry recognition of digital therapeutics as complementary rather than competitive therapeutic modalities.

LifeStance Health has signaled exploration of digital therapeutics acquisitions during Q1 2025 earnings calls, targeting tuck-in acquisitions that complement their behavioral health service delivery model and expand reimbursement capture capabilities.

Are there any early signs of successful clinical outcomes or reimbursement models that validate the commercial potential of these solutions?

Multiple reimbursement frameworks and positive real-world evidence studies demonstrate growing commercial validation for digital therapeutics, particularly in behavioral health applications.

Medicare reimbursement codes G0552, G0553, and G0554 enable billing for digital mental health devices and associated provider management time, creating sustainable revenue streams for psychiatric digital therapeutics. These codes support 90-day treatment episodes with reimbursement rates ranging from $85 to $150 per patient per month, depending on provider involvement levels.

Germany's Digital Health Applications (DiGA) pathway provides the most comprehensive reimbursement model globally, with approved digital therapeutics receiving €423 per 90-day activation period. This framework has enabled companies like Mindable Health and Selfapy to demonstrate positive unit economics while serving hundreds of thousands of patients.

Real-world evidence studies validate clinical efficacy claims across multiple therapeutic areas. Pear Therapeutics' reSET platform demonstrated 40% improvement in treatment retention rates compared to standard care in post-market surveillance studies involving over 4,000 patients. Big Health's SleepioRx showed 55% of users achieving clinically significant insomnia improvement within six weeks across health system pilot programs.

Outcomes-based contracts with major payers including Anthem, Aetna, and Kaiser Permanente provide risk-sharing models where digital therapeutics companies receive payment based on achieved clinical outcomes rather than traditional fee-for-service models. These arrangements demonstrate payer confidence in measurable patient benefit delivery.

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What regulatory or reimbursement hurdles remain for digital therapeutics to become mainstream, and how are companies navigating them?

Despite early reimbursement successes, digital therapeutics face significant regulatory and payer coverage limitations that constrain mainstream adoption across therapeutic areas.

Limited therapeutic scope represents the primary reimbursement hurdle, as current US Medicare codes apply exclusively to psychiatric digital therapeutics, excluding neurological, metabolic, and gastrointestinal applications. This restriction forces companies like Better Therapeutics (diabetes) and metaMe Health (IBS) to rely on direct-pay models or employer health benefits rather than traditional insurance coverage.

Efficacy claims alignment creates regulatory complexity, as FDA labels vary from "treat" to "aid in management" to "adjunctive," complicating payer coverage determination processes. Companies must navigate inconsistent clinical endpoint requirements and demonstrate superiority or non-inferiority to existing treatments to justify reimbursement.

Provider adoption barriers include limited electronic health record integration, clinician education requirements, and workflow disruption concerns that slow prescription rates even for reimbursed products. Digital therapeutics companies invest heavily in provider training programs and EHR partnership development to address these operational challenges.

Data security and privacy regulations create ongoing compliance costs and technical requirements, particularly as AI and machine learning components become more prevalent in digital therapeutics platforms. Companies must maintain HIPAA compliance, GDPR adherence, and emerging state-level privacy regulations while ensuring clinical efficacy.

Companies navigate these hurdles through outcomes-based contracting, real-world evidence generation, strategic health system partnerships, and regulatory pathway optimization including FDA's Software as Medical Device (SaMD) guidance and Pre-Cert program participation.

What are the most anticipated FDA submissions or market launches expected in 2026, and which ones could shift the market landscape?

2026 represents a potential inflection point for digital therapeutics market expansion, with anticipated FDA submissions spanning novel therapeutic areas and advanced technology platforms that could significantly broaden the addressable market.

Cognito Therapeutics' gamma wave neuromodulation platform for Alzheimer's disease represents the highest-impact potential approval, targeting a market with 6.7 million affected Americans and limited treatment options. Their sensory stimulation approach using light and sound to induce 40Hz gamma oscillations addresses neurodegeneration through a completely novel mechanism, potentially establishing digital therapeutics as primary rather than adjunctive therapy.

Next-generation oncology support applications including Untire's cancer-related fatigue management platform and Voluntis' symptom monitoring systems could establish digital therapeutics in cancer care workflows. These submissions target the 18 million cancer survivors in the US who experience persistent treatment-related symptoms poorly addressed by current pharmaceutical options.

Advanced sensor-integrated platforms from companies like Propeller Health for COPD and asthma management promise to demonstrate digital therapeutics efficacy in chronic respiratory diseases affecting over 40 million Americans. These connected inhaler platforms provide real-time medication adherence monitoring and environmental trigger identification capabilities.

Virtual reality exposure therapy applications from companies like Sympatient and AppliedVR could expand digital therapeutics into phobia treatment, PTSD management, and pain reduction applications. FDA approval of immersive technology platforms would validate digital therapeutics beyond traditional cognitive behavioral therapy approaches.

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Given current trends, what actionable strategies or areas of focus would be most useful for someone entering this market as an investor or entrepreneur?

Success in digital therapeutics requires focusing on differentiated clinical evidence, strategic payer partnerships, and seamless healthcare system integration rather than pursuing consumer-focused health applications.

• Evidence-Centric Development: Prioritize robust randomized controlled trial design with clinical endpoints aligned to existing reimbursement criteria. Target therapeutic areas with established health economic models and quantifiable outcome measures, such as reduced hospitalizations, medication adherence improvements, or functional status gains.
• Payer Engagement Strategy: Secure early pilot commitments from major health plans through outcomes-based contracts and risk-sharing arrangements. Focus on therapeutic areas with high medical costs and demonstrated ROI potential, particularly chronic diseases where digital therapeutics can reduce downstream healthcare utilization.
• Integration Infrastructure: Develop seamless electronic health record connectivity and clinical workflow integration to drive provider adoption. Partner with established healthcare technology platforms like Epic, Cerner, or Athenahealth rather than building independent systems.
• Therapeutic Differentiation: Target high-unmet-need areas including neurology, oncology support, and rare diseases where limited treatment options create clearer regulatory pathways and payer value propositions. Avoid crowded mental health markets unless offering significantly differentiated clinical approaches.
• Regulatory Strategy Optimization: Leverage FDA Software as Medical Device guidance and Pre-Cert program participation to expedite review timelines. Consider international markets including Germany's DiGA pathway and Canada's digital health regulations for faster revenue generation while pursuing US approvals.

Entrepreneurs should focus on building multidisciplinary teams combining clinical expertise, regulatory experience, and healthcare business development capabilities rather than traditional software development skills alone. Investors should evaluate companies based on clinical data quality, regulatory pathway clarity, and strategic healthcare partnerships rather than user engagement metrics typical of consumer health applications.

Conclusion

Sources

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2. Digital Therapeutics Alliance - DTx Definition and Core Principles
3. Digital Therapeutics Alliance - Understanding DTx
4. Cureus - FDA-Approved Digital Therapeutics Landscape
5. Eversana - Digital Health Policy Evolution
6. PharmiWeb - Digital Therapeutics Market Projections
7. FibriCheck - mHealth vs Wellness Apps
8. Medicai - Telehealth vs Telemedicine