The US Food and Drug Administration (FDA) has cleared Smileyscope’s virtual reality (VR) device, a system 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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”