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Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary ...
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Health
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United States
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Fusion42 · 24 August 2026 · Fusion42 review
Tempus received FDA 510(k) clearance for its AI software, Tempus ECG-PH, which analyzes standard 12-lead ECGs to detect signs of pulmonary hypertension, expanding its portfolio of FDA-cleared cardiovascular AI tools.
This Wire brief sits within Fusion42's coverage of Health.
◆ ◆ The Wire takeaway
Tempus' new FDA clearance opens a regulatory door for AI medical tools that detect difficult-to-diagnose heart conditions early. You in digital health can now push earlier screening tools into clinical workflows with less regulatory friction.
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1 source · 24 Aug 2026
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Healthfda-clearancecardiovascular-aipulmonary-hypertensionecg-analysishealthtech