Smileyscope has received FDA clearance for its flagship product Smileyscope Therapy, making it the first virtual reality (VR) device to receive FDA Class II clearance for acute pain, and the first and only VR Analgesic available in the US. The device is intended for children ages four and over and uses neuromodulation to control the way pain signals reach the brain.

Why it’s notable:

• Smileyscope has achieved a significant milestone by becoming the first virtual reality (VR) device to receive FDA Class II clearance for acute pain. This clearance is specifically for their flagship therapeutic, Smileyscope Therapy, making it the first and only VR Analgesic available in the US. The approval is based on Smileyscope's innovative Procedural Choreography technique, which replaces negative real-world stimuli with positive visual stimuli to reduce pain and anxiety during medical procedures.

• Smileyscope's FDA clearance is based on the evaluation of the world's largest randomised trials in procedural VR. These trials demonstrated substantial benefits, including up to a 60% reduction in self-rated pain, and 40% reduction in anxiety in children, in addition to benefits of up to 75% in caregiver distress and up to 48% reduction in the use of physical restraints, all of which underscore the therapeutic power of Smileyscope's VR Analgesic. 

Industry Implications: 

• Smileyscope is emerging as  a leader in Digital Therapeutics with this FDA clearance. Moreover, following the recent issuing of CPT codes from the American Medical Association, recognizing VR for the purposes of billing and documentation, Smileyscope's FDA clearance emerges as an important milestone for the industry. It not only signifies the first FDA-cleared VR Analgesic targeting acute pain, but also the first clearance of a therapeutic VR system designed specifically for the paediatric population.

• The medical community has rapidly embraced Smileyscope, with references in industry standards such as the Infusion Therapy Standards of Practice and recognition in UpToDate as a nonpharmacological intervention. Smileyscope has now been adopted in 100% of Australian Children’s Hospitals and the company is now focusing on expanding in the US. Recognition and approvals outside of Australia have further confirmed the strength of its data and the therapeutic power of the product.

Read the news story here.