AISAP has secured clearance from the U.S. Food and Drug Administration (FDA) for its Cardio POCUS (point-of-care ultrasound) system.
The cloud-based platform combines four computer-assisted diagnosis (CADx) modules of valvular pathologies and eight key measurements into a single cardiac ultrasound software package that automatically generates analyses, interpretations, and reports. The vendor-agnostic platform integrates into the clinical workflow, generating reports and offering telemedicine, cloud computing, and education tools.
AISAP trained Cardio on more than 24 million studies containing echo video clips. The platform shows sensitivity of 93% and specificity of 93%.
Cardio will be available for commercial use on September 1, AISAP said.
