ASX:PCKHealthcare Services
Should FDA De Novo Clearance for Adult App Prompt a Rethink by PainChek (ASX:PCK) Investors?
PainChek has received De Novo clearance from the US FDA for its Adult App, authorizing it as the first regulated medical device for pain assessment in individuals who cannot reliably self-report, including those with dementia, thus unlocking access to the US aged care market.
The clearance not only enables immediate US commercial rollout but also paves the way for expanded opportunities in international markets that recognize FDA data standards, such as Japan and Germany.
We'll now explore...