MedTech Strategist Market Pathways explores the people, challenges, and opportunities impacting the medtech regulatory and reimbursement community. Explore our coverage. Think Strategically. Subscribe Today.
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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Rachael Fleurence, the former executive director of NEST, heads up a consultancy focused on real-world evidence and innovative medtech research strategies. She offers her perspective on opportunities that are likely to arise out of the COVID-19 crisis to keep generating high-quality evidence while traditional studies are disrupted. These include significant changes to clinical trial protocol, including remote monitoring of participants, for which FDA has just issued guidance.
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The industry finds itself at the center of the response to a global crisis.
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