PainChek® secures FDA De Novo Clearance with clinical management from Donawa Lifescience

Donawa Lifescience congratulates PainChek Ltd on receiving United States (US) Food and Drug Administration (FDA) De Novo clearance for its PainChek® Adult Intelligent Pain Assessment App (DEN240073). This groundbreaking app is the world’s first smart device-based medical device for pain assessment, designed for individuals who are unable to reliably verbalize their pain.

The basis of the FDA’s decision was the ‘PainChek® US Validation Nursing Home Study’ (NCT06049732), a prospective, multicenter observational study designed to validate the app’s effectiveness in assessing pain in individuals with moderate-to-severe dementia. Managed by Donawa Lifescience, the study involved over 100 patients in five US nursing homes over a 16-week period, with each patient undergoing up to 10 paired pain assessments using PainChek® Adult and Abbey pain scale as a comparator.

This achievement reflects the long-standing collaboration between PainChek® and Donawa Lifescience, with Donawa’s expertise in US regulatory affairs and clinical study management for innovative medical technologies playing a key role in supporting PainChek’s successful De Novo submission.