BodyGuardian Remote Monitoring System V3 is a Phase 7 candidate from the FDA AI-enabled medical devices list. Maker: Boston Scientific Cardiac Diagnostic Technologies. Panel: Cardiovascular. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
CARTO 3 EP Navigation System V8.4 is a Phase 7 candidate from the FDA AI-enabled medical devices list. Maker: Biosense Webster. Panel: Cardiovascular. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
Clarius Ejection Fraction AI is a Phase 7 candidate from the FDA AI-enabled medical devices list. Maker: Clarius Mobile Health. Panel: Cardiovascular. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
ECG-AI Pulmonary Hypertension PH-12L Algorithm is a Phase 7 candidate from the FDA AI-enabled medical devices list. Maker: Anumana. Panel: Cardiovascular. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
Onera SleepMap is a Phase 7 candidate from the FDA AI-enabled medical devices list. Maker: Onera. Panel: Neurology. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
SafeBeat Rx App is a Phase 7 candidate from the FDA AI-enabled medical devices list. Maker: SafeBeat Rx. Panel: Cardiovascular. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
Validic Remote Patient Data Platform is a Phase 7 product-level candidate for interoperability coverage. HealthAIdir lists it as a conditional seed profile pending deeper vendor evidence review.
