Insufficient evidence / under studyC/DgradePlausibility · Plausible methodSensing Physics
One atlas entry for the AngioCode 'vascular-age' line. Photoplethysmography with pulse-wave contour analysis is a real, validated method; the consumer 'vascular age / cardiovascular diagnosis' interpretation overreaches the sensor. The registered indication is narrow; the marketing is broad.
Origin & lineage
Russian vascular-assessment line (AngioScan / AngioCode-301 / -322).
Claimed mechanism
Optical photoplethysmography (PPG) with pulse-wave contour analysis estimates 'vascular age' and cardiovascular risk.
Plausibility
Plausible method — PPG / contour analysis is validated; the broad 'vascular age' and risk-stratification interpretation is weakly validated and overreaches the sensor.
Evidence — grade C/D
Real, validated sensing method; the consumer diagnostic interpretation is weakly validated and broader than the registered indication.
Flag
narrow registered indication vs broad consumer marketing
Market
Makers: AngioScan / AngioCode line (RU). Models: AngioCode-322 (registered device); AngioCode-301 (household tracker, unregistered). Price: Not specified in source.
Kernel — keep vs set aside
Keep — real substrate
Photoplethysmography + pulse-wave contour analysis is a real, validated physiological measurement.
Set aside — claim
Consumer 'vascular age' / cardiovascular-diagnosis / home risk-stratification marketing is broader than the narrow registered indication (endothelial dysfunction & arterial stiffness). Registration is market access, not proof of efficacy for the broad claim.
Regulatory status by jurisdiction
Registration or clearance is a market-access fact, never proof of efficacy.
US — FDA
Not specified in source.
EU — MDR
Not specified in source.
Russia
AngioCode-322: Roszdravnadzor РЗН 2013/322, class 2a, registered 15.03.2013 — narrow registered indication: noninvasive assessment of endothelial dysfunction & arterial stiffness via a reactive-hyperemia / occlusion test. AngioCode-301: household tracker, no registration certificate (per its own leaflet).
РЗН number/class/date corroborated via registry aggregators (goszdravnadzor, nevacert); re-verify certificate РЗН 2013/322 at the Roszdravnadzor registry before publish.