FDA Approves First Virtual Reality Device for Acute Pain

The FDA has approved a virtual reality device, in what is being heralded as an industry first. 

Developed by Australian health care startup Smileyscope, the device uses VR therapies to reduce pain and anxiety during pediatric procedures. Patients wearing the VR headset see positive visual stimuli to distract children undergoing routine procedures such as injections or MRI scans.

Instead of a needle, the child will see, for example, fish nibbling on their arm or instead of an MRI machine, the child will see the inside of a spaceship. 

Keeping the patient engaged also allows staff to monitor their consciousness and stress levels, and helps assess whether certain procedures are appropriate.

Smileyscope's studies, which it said are the world's largest randomized trials in procedural VR, were reviewed by the FDA during the application assessment. 

Results showed children’s self-rated pain reduced by as much as 60% and anxiety by up to 40%. Studies also demonstrated benefits of up to 75% in caregiver distress and of up to a 48% reduction in the use of physical restraints. 

The company closed its seed funding round in October and the latest announcement marks a significant milestone in expanding its market standing and deploying its technology at hospitals around the world.

Related:Virtual Reality Pediatric Health Care Startup Closes Seed Funding Round

"Smileyscope is the only VR device worldwide purpose-built for procedural support,” said Paul Leong, Smileyscope's chief marketing officer. 

"We were thrilled to receive this FDA Class II clearance,” said Dr. Evelyn Chan, CEO and Smileyscope co-founder. “The FDA affirms Smileyscope's long-held position that we are a transformational, therapeutic VR device, raising the standard of care.".

Chan said the company plans to build on this success. 

“Our robust pipeline of drug-free pain and anxiety management treatments during common medical procedures spans children and adults,” Chan said.

“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."

It also marks the rise of digital therapeutics, a new category of medicine defined by Smileyscope as delivering medical interventions to patients using “evidence-based, clinically evaluated software." 

According to the company, the digital therapeutics market is expected to reach $32.5 billion by 2030. 

"We are truly excited to receive FDA clearance," said Gavin West, Smileyscope’s vice president 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 health care."