What You Should Know:
– Smileyscope™, a pioneer in virtual reality (VR) therapeutic solutions, has received Class II clearance from the U.S. Food and Drug Administration (FDA) for its Smileyscope™ Therapy system.
– The FDA clearance marks Smileyscope as the first and only VR Analgesic™ available in the US.
Digital Therapeutics Leadership
Smileyscope’s FDA clearance underscores its leadership in Digital Therapeutics, a category defined as delivering medical interventions directly to patients through evidence-based, clinically evaluated software. The Digital Therapeutics market is projected to reach 32.5 billion USD by 2030.
Procedural Choreography™ Patent
The FDA clearance included an evaluation of Smileyscope’s patented Procedural Choreography™ technique, a proprietary method that replaces negative real-world stimuli (e.g., a needle) with positive virtual stimuli (e.g., a friendly fish). This technique enhances safety and efficacy and serves as the foundation for future therapeutic products.
Clinical Trials
Smileyscope’s studies, the world’s largest randomized trials in procedural VR, demonstrated significant reductions in child self-rated pain (up to 60%) and anxiety (up to 40%). The trials also showed benefits in caregiver distress (up to 75%) and a reduction in the use of physical restraints (up to 48%).
Future Expansion
Smileyscope aims to build on this success with a robust pipeline of drug-free pain and anxiety management treatments for common medical procedures across age groups. The company envisions widespread adoption in hospitals, doctor’s offices, and an expanded range of patients benefiting from their drug-free treatments.
“We were thrilled to receive this FDA Class II clearance. The FDA affirms Smileyscope’s long-held position that we are a transformational, therapeutic VR device, raising the standard of care,” said Dr. Evelyn Chan, CEO and co-founder of Smileyscope.