Top 16 Digital Therapeutics Companies Worth Considering in 2026

Published Feb 2, 2023
Updated Jul 23, 2026
11 min read
Omada, Virta, One Drop, Lark, and many other DTx companies are making a real difference in the way healthcare is delivered. Read more about today’s DTx disruptors.
Quick AI Summary in 100 Words
The digital therapeutics market, valued at $8.21B in 2024, is projected to reach $53.15B by 2032 (CAGR 26.3%). Leading companies like Omada, Virta Health, Biofourmis, Akili, Welldoc, and others innovate in areas like diabetes reversal, AI-powered chronic care, video-game therapies, and musculoskeletal pain management, leveraging digital platforms, FDA-approved tech, and behavioral science to improve patient outcomes.

Frequently Asked Questions

Do digital therapeutics need FDA approval?

Depending on the particular product and its intended use, digital therapies, also known as software as a medical device (SaMD), may need FDA authorization or approval. A risk-based approach will be used by the FDA to decide whether a product should be categorized as a medical device and consequently be subject to regulatory monitoring, according to advice the FDA has given on the regulation of digital health goods. This implies that although certain goods may not need FDA clearance or approval, those that represent a lesser risk to human safety may be subject to stricter regulation.

What is the right business model for digital therapeutics?

While choosing a business model, pay attention to the target patient group, the nature of digital therapy, and the competitive environment. It is critical to select a model that matches the company's aims and objectives while also assuring long-term viability and profitability.

  • Subscription-based: Charge a recurring fee for access to the digital therapeutic platform.
  • Outcome-based pricing: Receive payment based on the achievement of certain outcomes or metrics.
  • Pay-per-use: Charging a fee for each session or interaction with the digital therapeutic.
  • B2B licensing: License the technology to healthcare providers or payers for use in their own patient populations.
  • Advertising-based: Generate revenue by advertising or posting sponsored content on the platform.
  • Combination model: Use a combination of several business models to diversify revenue streams.

How can DTx companies create products that fit into provider workflows?

What do payers want? Before they sign off on any reimbursements, payers want to see evidence of treatment success. Everything is interconnected. If DTx firms pursue FDA regulation and regularly demonstrate their product's potential to offer excellent health outcomes and efficiency advantages, they will win over physicians who will subsequently suggest them to their patients.

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