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4 companies sign on to FDA's digital device pilot
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Fusion42 · 4 September 2026 · Fusion42 review
The FDA has selected four companies to participate in its TEMPO pilot for digital health devices focused on managing chronic diseases, including tools using generative AI. The pilot will evaluate real-world performance data and aligns with CMS’s ACCESS payment model to expand tech-supported care for Medicare patients.
This Wire brief sits within Fusion42's coverage of Digital Health.
◆ ◆ The Wire takeaway
As the FDA opens regulatory pathways for AI-driven digital health devices, you must move quickly to meet emerging guidelines and tap into Medicare’s growing tech-access programs. This is your chance to position for early market access in chronic disease care.
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1 source · 3 Sep 2026
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