Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs
Tempus AI received FDA 510(k) clearance for Tempus ECG-PH, an AI-enabled software designed to detect signs of pulmonary hypertension from standard 12-lead ECGs. This clearance adds to Tempus' existing FDA-cleared portfolio for atrial fibrillation and low ejection fraction, marking the third cardiovascular device authorized by the agency.
Key figures
- Portfolio device count
- 3
- Target patient age min
- 40 years
- Condition prevalence general
- roughly 1%
- Condition prevalence seniors
- up to 10%
AI analysis
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