Smileyscope has made history by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This approval recognizes Smileyscope's innovative Procedural Choreography™ technique, which uses positive virtual stimuli to reduce pain and anxiety during medical procedures. With this milestone, Smileyscope aims to revolutionize pain and anxiety management, partnering with hospitals and clinicians globally to enhance patient experiences and improve clinical workflows.
WASHINGTON, Nov. 6, 2023 /PRNewswire-PRWeb/ -- The FDA has granted Class II clearance to Smileyscope™ Therapy, making Smileyscope Therapy the first and only VR Analgesic™ available in the US. Smileyscope is the premier provider of drug-free pain and anxiety treatments for procedures, worldwide.
FDA clearance of Smileyscope's flagship therapeutic highlights Smileyscope's position as a leader in Digital Therapeutics. Digital Therapeutics are "a new category of medicine" which "deliver medical interventions directly to patients using evidence-based, clinically evaluated software" (1) achieving clinically important effects. The Digital Therapeutics market is expected to reach 32.5 billion USD by 2030. (2)
Shortly after the close of their funding round, Smileyscope attained another major accomplishment on September 25th, 2023 when FDA cleared their groundbreaking VR system to "temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures."
FDA clearance included critical, independent evaluation of Smileyscope's patented Procedural Choreography™. Procedural Choreography is Smileyscope's proprietary technique that takes negative real-world stimuli (e.g. a needle) and replaces it with psychologically-preferable positive virtual stimuli (e.g. a friendly fish). Granted in 2022, Smileyscope's Procedural Choreography patent powers an unmatched safety and efficacy profile and underlies future therapeutic products.
Smileyscope's studies, the world's largest randomized trials in procedural VR, were reviewed by the FDA during the Class II filing. These demonstrated reductions in child self-rated pain of up to 60% and anxiety of up to 40%, laying the clinical groundwork for this first-ever clearance of a VR device for acute pain and anxiety. Studies also demonstrated benefits of up to 75% in caregiver distress and of up to 48% reduction in the use of physical restraints. (3)
The medical community has rapidly embraced Smileyscope. The Infusion Therapy Standards of Practice (4) uniquely cites Smileyscope's studies for management of vascular access pain. Smileyscope's trials are referenced in UpToDate®, the healthcare industry-leading clinical decision resource, as a nonpharmacological intervention which may avoid procedural sedation (5). Only months after the American Medical Association issued CPT® codes recognizing VR, Smileyscope's FDA clearance is an important milestone for the industry. Smileyscope's clearance represents not only the first FDA-cleared VR Analgesic for acute pain, but also the first clearance of a therapeutic VR system for the pediatric population.
"Smileyscope has now transformed over 100,000 procedures globally. Building on regulatory approvals in three other geographies, this confirms the strength of our data and the therapeutic power of our product," said Dr. Paul Leong, Smileyscope's Chief Marketing Officer and co-founder. "Smileyscope is the only VR device worldwide purpose-built for procedural support."
"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.
"We will build on this success. Our robust pipeline of drug-free pain and anxiety management treatments during common medical procedures spans children and adults. We look forward to the future where Smileyscope is in every hospital room, every doctor's office, and every patient can benefit from our drug-free treatments," said Chan.
"We are truly excited to receive FDA clearance. It is another recognition of our industry-leading status, along with best-in-class efficacy, best-in-class ease of use, and standard-elevating features like Procedural Choreography," said Gavin West, VP of Sales and Marketing. "Results like this are what is driving the VR/XR and digital health spaces, making them amongst the fastest growing segments of healthcare."
To learn more about Smileyscope, please visit www.smileyscope.com.
Smileyscope is a multi-award-winning digital therapeutics company with proprietary technology that reframes medical procedures using choreographed virtual-reality (VR) experiences to help reduce patient pain and anxiety, improving patient experience and improving clinical workflows. Smileyscope Therapy is FDA-cleared for acute pain and anxiety reduction for needles procedures in children. Globally, Smileyscope has been utilized by clinicians across a range of medical procedures such as vaccines, bloodwork, wound dressings, anesthetic inductions, cast applications/removals, medical imaging and avoiding sedation. Smileyscope has partnered with over 50 US hospitals to implement the technology.
Smileyscope, VR Analgesic and Procedural Choreography are registered trademarks of Smileyscope Holding Inc. The names and logos of third-party products and companies are the property of their respective owners and may also be trademarks. All trademarks, service marks and company names (e.g. AMA CPT®, UpToDate®) are the property of their respective owners.
Digital Therapeutics Alliance, Understanding DTx, Accessed October 31 2023
Research and Markets, Digital Therapeutics Market Size, Share & Trends Analysis, 2023-2030, Accessed October 31 2023
Chan E, et al. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. The Journal of Pediatrics. 2019;209:160–7.
Gorski LA, et al. Infusion Therapy Standards of Practice, 8th Edition. Journal of Infusion Nursing. 2021;44(1S):S1–224.
Cravero JP, Roback MG. Procedural Sedation in Children: Approach. UpToDate, Accessed September 25 2023.