Tempus AI Wins FDA Clearance for AI Tool That Flags Pulmonary Hypertension From ECGs
TEM sits 73% above its 52-week low of $40.77 on elevated volume (2.4× avg).
Summary
Tempus AI received FDA 510(k) clearance for Tempus ECG-PH, an AI software device that analyzes standard 12-lead ECGs to detect signs of pulmonary hypertension. This is the company's third FDA-cleared cardiovascular device, expanding its AI diagnostics portfolio. The clearance adds a new revenue-generating product in a large, underdiagnosed patient population—up to 10% of adults over 65. It follows the recent FDA approval of the tumor-only xT CDx assay and the $1.5B Personalis acquisition, reinforcing Tempus's regulatory momentum. The device is intended as a screening aid, not a standalone diagnostic, and is limited to patients 40+ with cardiovascular symptoms.
At the time of this announcement, TEM was trading at $70.45 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $13.1B. The 52-week trading range was $40.77 to $104.32. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.