Platform insight
AgeVision CORE.
MDR Class I perimeter.
CORE is presented around an intended purpose of collecting, organising, displaying and supporting continuity of information. The platform does not claim autonomous diagnosis, therapeutic decision-making or clinical prediction.
Intended purpose first
Classification starts
from what the software is intended to do.
AgeVision communication deliberately separates wellness and sport from CORE. Any future function intended to drive diagnostic or therapeutic decisions, or to perform clinical physiological monitoring, would require a new regulatory assessment before release.
CORE scopeCollection, organisation, display and continuity of information.
No autonomous diagnosisClinical responsibility remains with the qualified professional.
No clinical prediction claimMarketing does not position AgeVision as predictive clinical software.
Change controlNew intended functions require regulatory review before launch.