PainChek® is an FDA De Novo–granted, AI‑enabled medical device that gives a voice to people who cannot verbalize their pain. Using facial recognition and a guided behavioral framework, PainChek identifies and measures pain quickly and accurately. It generates a validated pain score, providing a reliable evidence base for clinical decision‑making and ongoing treatment monitoring. This modern approach supports timely, person‑centered pain management for individuals living with moderate to severe dementia.