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Tempus Receives FDA Clearance for its ECG-MR AI Product Designed to Identify ...
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Fusion42 · 29 September 2026 · Fusion42 review
Tempus AI received FDA 510(k) clearance for Tempus ECG-MR, an AI software analyzing 12-lead ECGs to detect undiagnosed moderate or severe mitral regurgitation in patients 65 or older at risk of cardiovascular disease.
This Wire brief sits within Fusion42's coverage of Health, and 2 sources have reported it between 28 Sep 2026 and 6 Oct 2026.
◆ ◆ The Wire takeaway
You have a new AI tool approved to detect serious heart valve disease early from a standard ECG. Cardiovascular AI startups should engage clinicians to integrate this diagnostic upgrade into routine care.
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2 sources · first reported 28 Sep 2026 · latest 6 Oct 2026
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