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First Virtual Reality Pain Device Approved by FDA

The Smileyscope-developed tool is intended to lessen discomfort and anxiety during paediatric treatments.

An industry first, the FDA’s approval of a virtual reality gadget has been hailed.

Smileyscope, an Australian health firm, created a gadget that employs virtual reality (VR) therapy to lessen pain and anxiety during paediatric operations. Children receiving standard treatments like injections or MRI scans are distracted by pleasant visual stimuli shown to patients wearing VR headsets.

For example, the youngster may see fish nibbling on their arm in place of a needle, or they may see the inside of a spacecraft in place of an MRI machine.

Maintaining the patient’s engagement also enables the personnel to keep an eye on their level of awareness and stress and determine if certain operations are necessary.

The FDA evaluated Smileyscope’s research during the application evaluation, claiming that they are the biggest randomised trials in procedural VR in the world.

The children’s self-rated pain decreased by up to 60% and their anxiety by up to 40%, according to the results. Research has further shown advantages of up to 75% less carer discomfort and up to 48% less usage of physical restraints.

With the most recent news, the firm has reached a major milestone in growing its market position and implementing its technology in hospitals worldwide. The company finished its initial fundraising round in October.

According to Paul Leong, Chief Marketing Officer, Smileyscope is the sole VR device designed precisely for offering procedural-type assistance.   

Dr Evelyn Chan, Co-founder and CEO, Smileyscope, said that the company’s team was ecstatic after receiving FDA Class II-level clearance. Smileyscope’s long-standing claim that it is a revolutionary, therapeutic virtual reality technology that raises the bar for treatment is supported by the FDA.

The business intends to expand on this success, according to Chan.

Chan said that the organisation currently possesses a robust range of drug-free anxiety and pain controlling treatment modes for youngsters as well as grown ups, while medical processes are going on.

She elaborated further, stating that there is hope for a time in the future where Smileyscope becomes a mainstay across doctor’s clinics and hospitals, implying that patients can easily access non-pharmaceutical treatments. 

Additionally, it heralds the emergence of digital therapies, a brand-new field of medicine that Smileyscope defines as providing patients with medicinal treatments via the use of clincally approved applications that are based in proof.

The business projects that by 2030, the market for digital therapies would grow to $32.5 billion.

Vice president of sales and marketing at Smileyscope Gavin West expressed his excitement at receiving FDA certification. He said that these kinds of outcomes are propelling the digital health and VR/XR industries, which are arguably the most rapidly expanding in the medical field.

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