Smileyscope, a trailblazer in virtual reality (VR) therapeutic solutions, has secured Class II clearance from the U.S. Food and Drug Administration (FDA) for its Smileyscope Therapy system, distinguishing it as the first and exclusive VR Analgesic available in the U.S.
The company's leadership in Digital Therapeutics, delivering medical interventions directly to patients through evidence-based, clinically evaluated software, is underscored by this FDA clearance. The Digital Therapeutics market, projected to reach $32.5 billion USD by 2030, positions Smileyscope at the forefront of transformative healthcare technology.
The FDA clearance involves an assessment of Smileyscope's patented Procedural Choreography technique, a proprietary method that substitutes negative real-world stimuli (e.g., a needle) with positive virtual stimuli (e.g., a friendly fish). This innovative approach enhances safety and efficacy, laying the groundwork for future therapeutic products.
Smileyscope's extensive studies, recognised as the world's largest randomised trials in procedural VR, exhibited substantial reductions in child self-rated pain (up to 60%) and anxiety (up to 40%). The trials also showcased benefits in caregiver distress (up to 75%) and a notable reduction in the use of physical restraints (up to 48%).
With this FDA clearance, Smileyscope is poised for future expansion. The company aims to leverage its success by developing a robust pipeline of drug-free pain and anxiety management treatments applicable to common medical procedures across diverse age groups. Smileyscope envisions widespread adoption of its innovative, drug-free solutions in hospitals, doctor's offices, and an expanded range of patients benefiting from these transformative therapies.
Dr. Evelyn Chan, CEO and co-founder of Smileyscope, expressed excitement about the FDA Class II clearance, highlighting its affirmation of Smileyscope as a transformative, therapeutic VR device that elevates the standard of care.
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