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Tempus AI (TEM) Is Up 6.1% After New FDA-Cleared ECG PH Tool
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Fusion42 · 28 August 2026 · Fusion42 review
Tempus AI received FDA 510(k) clearance for Tempus ECG-PH, an AI diagnostic tool for detecting pulmonary hypertension via standard ECGs in symptomatic adults over 40. This new clearance extends Tempus AI's cardiovascular AI diagnostics portfolio and reinforces its strategy to build ‘dry lab’ software tools contingent on reimbursement and adoption.
This Wire brief sits within Fusion42's coverage of Digital Health, and 3 sources have reported it between 24 Aug 2026 and 28 Aug 2026.
◆ ◆ The Wire takeaway
Your Digital Health AI tool just cleared a major US regulatory hurdle, opening a corridor for reimbursement negotiations. Speed your payer discussions while competitors trail behind this FDA validation.
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3 sources · first reported 24 Aug 2026 · latest 28 Aug 2026
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