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Wire · opportunities

FDA clears AI software for detecting untreated pulmonary hypertension in 12-lead ECGs

24 August 2026 · By · Wire by Fusion42

Published

24 August 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at cardiovascularbusiness.com →

◆ Verified

Fusion42 · 24 August 2026 · Fusion42 review

Tempus AI has received FDA clearance for Tempus ECG-PH, an AI-powered software that detects signs of pulmonary hypertension using 12-lead ECGs, aimed to assist clinicians in earlier risk identification but not for standalone diagnosis.

This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it.

◆ ◆ The Wire takeaway

Medtech founders in cardiovascular AI now have a clearer market path in the US after this clearance. You should prioritise clinical partnerships to integrate your AI tools with diagnostic workflows.

◆ Coverage

2 sources · 24 Aug 2026

◆ Related on Wire

◆ Topics

Medtechfda-clearanceai-healthpulmonary-hypertensionecgtempus-ai