PainChek Ltd, the developer of the world’s first smartphone-based pain assessment and monitoring application, announced that the PainChek Infant Face-Only clinical study to support CE Mark and TGA regulatory clearance was successfully completed, with the findings supporting the use of the app for procedural pain assessment with infants. A publication detailing the findings of the study has been written and submitted to a scientific journal for peer review.
PainChek is a smartphone-based medical device using artificial intelligence to assess and score pain levels in real-time and update medical records in the cloud. PainChek records a short video of the person’s face and analyses the images that indicate pain and records them.
Next, the caregiver uses PainChek to record their observations of other pain-related behaviours that complete the assessment. Finally, PainChek calculates an overall pain score and stores the result allowing the caregiver to monitor the effect of medication and treatment over time.
PainChek is being rolled out globally in two phases: first, PainChek for adults who are unable to effectively verbalise their pain such as people with dementia, and second, PainChek for Children who have not yet learnt to speak.
PainChek is on schedule for Australian (TGA) and European (CE Mark) regulatory clearance of the PainChek Infant product in Q2 calendar 2021 followed by a market launch in these territories. The recent clinical study results should support these market launches.
PainChek CEO Philip Daffas is confident, "With 400 million pre-verbal children worldwide at any one time, including an estimated 100 million with first-time parents each year, there appears to be an outstanding market opportunity for PainChek Infant across various settings including hospital, home care and primary care."