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Tempus AI receives FDA clearance for pulmonary hypertension tool
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Fusion42 · 25 August 2026 · Fusion42 review
Tempus AI received FDA 510(k) clearance for its AI software Tempus ECG-PH, designed to detect signs of pulmonary hypertension via 12-lead ECG analysis, offering a non-invasive diagnostic aid for patients 40 and older with cardiovascular symptoms.
This Wire brief sits within Fusion42's coverage of Digital Health, and 4 sources have reported it between 24 Aug 2026 and 28 Aug 2026.
◆ ◆ The Wire takeaway
You have a clearer path to integrate AI diagnostics into cardiology workflows in the US as non-invasive pulmonary hypertension screening moves closer to routine care. This FDA clearance opens doors for earlier patient risk identification without invasive testing.
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4 sources · first reported 24 Aug 2026 · latest 28 Aug 2026
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