SAM #75F40126Q00193

FDA CDRH Clinical Study Service Contract for AI/ML ECG Validation

The U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), is seeking a contractor to support regulatory evaluation of cardiovascular devices with a clinical study service contract. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Office of Health Technology II (OHTII) - Services Requested: - Clinical study service contract to validate an AI/ML-enabled ECG signal transformation framework - Prospective clinical study recruiting 150 subjects for ECG data collection, annotation, and delivery - Preparation of a retrospective paired synthetic ECG dataset for at least 4,000 subjects - Delivery of clinical protocols, IRB approval, curated datasets, synthetic signal datasets, monthly progress reports, and final comprehensive reports - Unique/Notable Requirements: - Focus on AI/ML-based signal analysis and synthesis of wearable ECG signals - Deliverables must support regulatory evaluation and public dissemination - Aims to reduce duplicative clinical studies for cardiovascular devices - No specific OEMs or vendors are named in the solicitation - No product part numbers or commercial equipment specified; the opportunity is service-focused

Description

See attached RFQ

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