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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

Business Strategies

Caption Health: Transforming Cardiac Imaging with AI

In keeping with its proactive stance on establishing a regulatory framework for the upcoming wave of AI-based software technologies, the FDA in February granted de novo authorization for the first AI-based product for acquiring cardiac ultrasound images. Deployment has begun in high-need acute point-of-care settings, including those treating COVID-19 patients.

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