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Simplex Quantum

Shibuya-ku, Tokyo, Japan

Ownership: Private
Development stage: Other

Overview

Simplex Quantum’s AI-based system for early heart failure detection (NIHA-HF), developed in partnership with the University of Tokyo Hospital, is undergoing clinical trials for PMDA submission, with a pre-submission to the US FDA underway. Their commercial medical device, Shinden-kun, has already received Japanese PMDA approval for atrial fibrillation detection. Clinical data references analysis of ~600,000 ECGs.

Therapeutic areas: Cardiovascular
Modalities: DeviceArtificial intelligence software
Industry: Physiological Monitoring

Partnerships

University of Tokyo HospitalJapan Agency for Medical Research and Development (AMED)Simplex HoldingsITOCHU Corporation

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