The US Food and Drug Administration (FDA) has cleared Smileyscope’s virtual reality (VR) device, which replaces painful or anxiety-inducing stimuli with friendly imagery.
As per the FDA, the headset is cleared to temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures.
According to Smileyscope, the clearance means the device has become the first VR analgesic to become regulatory authorised in the US for acute pain.
Australia-headquartered Smileyscope rolled out its system at The Nicklaus Children’s Hospital in Miami, US, to help patients through needle procedures. Known as trypanophobia, needle phobia is a recognised condition that is estimated to affect two-thirds of children.
Smileyscope stated that the clearance is also the first for a therapeutic VR system for paediatric patients.
The global VR market, which, according to a report by GlobalData is forecast to be worth $51bn by 2030, is seeing increased utilisation in healthcare – an emerging use is for the treatment of phobias.
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Smileyscope calls its technology Procedural Choreography, where negative stimuli are replaced virtually with friendly ones.
Speaking to Medical Device Network in June 2023, Smileyscope CEO Evelyn Chan said: “We partnered with ex-Disney producers to create our therapeutic animations where waves wash over virtual arms during antiseptic cleaning and fish nibble when clinicians insert the needle.
“We patented this technology and called it ‘Procedural Choreography’, in which we substitute real-world negative stimuli for virtual stimuli filled with positive and friendly images.”
Smileyscope submitted data to the FDA from randomised trials investigating the use of its procedural VR system in pain management. According to the company, the use of the device in children led to a reduction of up to 60% in self-rated pain and 40% in anxiety.
In a statement announcing the FDA clearance, Chan said: “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.”