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Smileyscope Therapy
VR Analgesic

First and Only FDA-Cleared Virtual Reality Analgesic™ for Acute Pain*


This page is intended for healthcare professionals.

A New Era: Drug-Free VR Analgesia

Clinically-proven safety and efficacy

First and only FDA-cleared VR for Acute Pain*


#1 in ease-of-use. Advanced antimicrobial impregnation

Cleared for patients as young as 4 years*, 12 languages including Spanish


How does Smileyscope work?

Smileyscope reduces pain and anxiety during needle experiences.

Clinician introduces Smileyscope to a patient to reduce pain and anxiety during needle procedures

Real world sensations are reframed in the VR world in a supporting and engaging way

Pain, anxiety, and experiences are improved for patients, families and clinicians

What is Smileyscope?



Smileyscope Therapy Mode is used during needle procedures, reducing pain and anxiety. It comes as an integrated, ready-to-go hardware and software solution.

Smileyscope virtual reality is FDA-cleared for ages 4-11 years.

Easy-to-clean: just wipe down with alcohol-based wipes.

US patent 11,216,063, further US and international patents pending.

How does
it work?

*Indications For Use

The Smileyscope System’s Therapy Mode is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on guided relaxation and other evidence-based behavioral methods for patients aged 4-11 years who can cooperate and interact with the device at a developmentally appropriate level. The Smileyscope Therapy Mode is intended to temporarily reduce and/or manage pain and temporarily relieve acute procedural anxiety associated with needle procedures (e.g., venipuncture, IV placement, vaccination, port access, subcutaneous injections). The device is not intended to treat anxiety disorders or specific phobias (e.g. trypanophobia).


Epilepsy, contact infection control precautions, poor skin integrity in the regions where the device resides, neuromuscular compromise if the weight of the device would result in injury, known skin hypersensitivity reactions to any of the components, unstable, deteriorating or critically unwell clinical status, pacemaker or other electronic implanted medical device.


  1. Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, et al. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. The Journal of Pediatrics. 2019 Apr 29;209:160–7. 

  2. Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLOS ONE. 2018 Jul 27;13(7):e0200987.

  3. Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, et al. Infusion Therapy Standards of Practice, 8th Edition. Journal of Infusion Nursing. 2021 Jan;44 (1S):S1–224. 

  4. Cravero JP, Roback MG. Procedural Sedation in Children: Approach. UpToDate, Accessed September 2023.

  5. Joint Commission on Accreditation of Healthcare Organizations. Restraint and Seclusion: Complying with Joint Commission Standards. Joint Commission Resources; 2001. 

"My child has had
over 300 procedures.
This was the first time 
he has not cried"

Parent of a 5 year old

 Patient in clinical trial who did not receive compensation and is not an immediate family member, of an individual who is involved with the production, sale, supply or marketing of the goods.

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Everyone loves Smileyscope


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