PainChek Infant App: regulatory cleared for sale in multiple markets

World first facial recognition technology to assess pre-verbal infant procedural pain – in real time and at the point-of care through a 3 second AI based video analysis of the face

Regulatory clearance in Australia, UK, Europe, Singapore, Canada and New Zealand Q1 2021 – US FDA in progress

PCK infant clinical study published in Lancet Digital Health September 2021

Infant Brochure DownloadTarget User Sectors

Clinical Trials
Children’s Hospitals
Post surgical units
Health care professionals
General Practitioners
Day care workers

PainChek Infant Clinical Study published by Lancet Digital Health

  • Renowned journal Lancet Digital Health published – “Assessing procedural pain in infants: a feasibility study evaluating a point-of-care mobile solution based on automated facial analysis1
  • PainChek Infant’s validity and reliability was assessed against the paper-based Neonatal Facial Coding System Revised (NFCS-R), and the observer administered Visual Analogue Scale (ObsVAS)
  • Study used video recordings of 40 infants aged 2 to 7 months of age, with more than 4,300 pain assessments completed in two separate evaluation sessions, four weeks apart
  • PainChek Infant pain scores demonstrated excellent correlation with NFCS-R and ObsVAS scores, moderate to excellent inter-rater reliability and high levels of internal consistency
  • The findings provide evidence that PainChek Infant offers valid and reliable means of assessing and monitoring procedural pain in infants


The Lancet

New Study confirms difficulty in assessing pain in pre-verbal patients1

  • Facial expressions noted as one of the most important cues to assess pain in infants²
  • Recognising pain by observing the face is challenging
  • Barros et al¹ recent study found:
    – Only 80 out of 143 adults correctly identified pain/no pain in newborns
    – Health professionals were able to more accurately identify pain/no pain
  • Findings provide further evidence of need for automated facial assessment of pain in infants
  • PainChek® Infant automatically identifies facial features indicative of pain irrespective of who assesses it (ICC=0·81-0·97, p<0·001).

1. de Moraes Barros MC, Thomaz CE, da Silva GV, Soares JD, Carlini LP, Heiderich TM, Orsi RN, Balda RD, Silva PA, Sanudo A, Andreoni S. Identification of pain in neonates: the adults’ visual perception of neonatal facial features. Journal of Perinatology. 2021 12:1-5.
2. Pillai Riddell RR, Horton RE, Hillgrove J, Craig KD. Understanding caregiver judgments of infant pain: contrasts of parents, nurses and pediatricians. Pain Research Management 2008;13:489–96.

PainChek Infant App –  Initial Target Markets

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1. Post vaccination

Approximately 140 million infants worldwide
- 95% fully immunised at 12 months after five immunization appointments1
- Covid -19 infant vaccination clinical studies ongoing with clear need to understand the occurrence of post vaccination pain

1 Australian data

2. Post operative

Pain associated with surgical procedures (e.g. post tonsillectomy) & where parents are required to deliver pain management in the home


3. Partnerships & licensing

Collaboration with global therapeutic companies providing vaccination and pain medications for use by healthcare professional and families

Intended Use


PainChek Infant is intended for use to assess procedural pain associated with medical investigations or treatments including; immunisations, suturing & dressing changes, invasive procedures such as fracture reductions or bone marrow biopsies.

Users of PainChek Infant


Users of PainChek Infant can include healthcare professionals or laypersons, in settings including clinical studies, hospitals, day surgery centres, GP clinics or the home.