First FDA cleared non-drug treatment for generalized anxiety disorder.
Clearance is the second FDA-clearance for Big Health.
Big Health, a leading developer of digital mental health treatments, has been granted clearance by the U.S. Food and Drug Administration (FDA) for its digital therapeutic, DaylightRx. DaylightRx is a prescription device delivering Cognitive Behavioral Therapy and can be made available on the order of a licensed healthcare provider. DaylightRx is a digital therapeutic intended to treat generalized anxiety disorder (GAD) by improving a patient’s GAD symptoms as an adjunct to usual care.
DaylightRx is the first FDA-cleared digital treatment for generalized anxiety disorder. DaylightRx is an innovative digital formulation of cognitive behavioral therapy for GAD that teaches patients evidence-based techniques to change the thoughts and behaviors that maintain chronic worry and anxiety. The 90-day treatment includes interactive lessons on applied relaxation to reduce tension, stimulus control to decrease worry frequency, cognitive restructuring to break the spiral of anxious thoughts, and exposure to reduce intensity of worry.
DaylightRx has demonstrated efficacy in treating generalized anxiety disorder in randomized controlled trials, showing rates of remission of over 70%, and significantly reducing anxiety up to 6 months or more.
This is Big Health’s second FDA-cleared product this year. SleepioRx was cleared for insomnia disorder last month. In addition, the 2025 Medicare Physician Fee Schedule proposed rule included a proposal to, for the first time, pay for FDA-cleared digital mental health treatments. This establishes a promising pathway to scale access to both SleepioRx and DaylightRx, and similar digital therapeutics that are deployed in clinical practice and can help address the significant unmet mental health need nationwide.
“For too long, patients seeking non-drug treatment options for anxiety have had limited choices. Now, with our FDA-cleared treatment, we’re offering a powerful alternative with remission rates of over 70 percent. With this clearance, there is now an accessible non-medication option that patients can trust,” shared Big Health CEO Yael Berman.
DaylightRx was developed based on Big Health’s existing digital care program, Daylight, which has been providing accessible, effective support to those struggling with feelings of worry and anxiety for over five years. Big Health will continue to offer Daylight, and its broader suite of clinically-proven digital care programs to millions of members covered by employers, health plans, and international health systems.
GAD is a chronic and debilitating condition in which patients experience excessive, uncontrollable worry that is associated with physical symptoms and significant interference in day-to-day functioning. Generalized anxiety disorder has also been associated with increased risk for a number of other conditions, including depression, diabetes, heart disease, and hypertension. Anxiety disorders, including GAD, are some of the most common and costly mental health conditions with a cost to U.S. economy of over $53B per year.
About Big Health
Big Health’s mission is to help millions back to good mental health by providing digital treatments and programs for the most common mental health conditions, including insomnia, anxiety, and depression. Designed by leading experts, Big Health’s clinically proven programs expand access to gold standard behavioral techniques and are backed by over 90 industry-leading research publications and 18 randomized controlled trials. Big Health has been partnering with employers, health plans, and international health systems for over a decade to provide inclusive, scalable, and affordable mental health care. For more information, please visit www.bighealth.com or follow Big Health on LinkedIn.
About Gilde Healthcare
Gilde Healthcare is a transatlantic specialist investment firm managing over €2.6 billion across two fund strategies: Venture&Growth and Private Equity. The Venture&Growth fund of Gilde Healthcare invests in fast growing companies active in digital health, medtech and therapeutics, based in Europe and North America. The Private Equity fund of Gilde Healthcare participates in profitable lower mid-market healthcare companies based in North-Western Europe. For more information, visit the company’s website at www.gildehealthcare.com.
