TLDR
- Tempus AI received FDA 510(k) clearance for its ECG-PH software, which uses AI to detect signs of pulmonary hypertension from standard 12-lead ECGs.
- This is Tempus’ third FDA-cleared cardiovascular AI product, joining tools for atrial fibrillation and low ejection fraction.
- Pulmonary hypertension affects roughly 1% of the population and up to 10% of adults over 65.
- The device is not a standalone diagnostic tool and must be used alongside other clinical information.
- The software only works on patients aged 40 or older who have cardiovascular symptoms and no prior PH diagnosis.
Tempus AI (TEM) has received FDA 510(k) clearance for Tempus ECG-PH, an AI-powered software tool designed to detect signs of pulmonary hypertension using standard 12-lead electrocardiograms.
The clearance marks the third FDA-approved cardiovascular AI product in Tempus’ portfolio. The company already holds clearances for tools targeting atrial fibrillation and low ejection fraction.
Pulmonary hypertension is caused by stiffening and narrowing of the blood vessels in the lungs, which puts pressure on the right side of the heart. It affects around 1% of the general population and up to 10% of adults over 65.
Despite how common it is, PH is frequently missed. Early symptoms like fatigue and shortness of breath are easy to overlook, and the standard diagnostic process typically involves an invasive procedure called right heart catheterization.
That’s where Tempus ECG-PH comes in. The software analyzes resting, non-ambulatory 12-lead ECG recordings and flags signs of elevated mean pulmonary artery pressure, an indicator of PH.
Who the Tool Is For
The device is designed for use on patients aged 40 and older who have cardiovascular symptoms such as dyspnea, fatigue, chest pain, or edema, and who do not already have a known PH diagnosis.
It provides a binary output, meaning it either flags the indicator or it doesn’t. Clinicians are expected to use the result alongside the patient’s full clinical picture.
Tempus is clear that this is not a standalone diagnostic. Results must be interpreted with the patient’s original ECG, symptoms, test history, and other clinical data.
The tool cannot be used for serial monitoring and is not suitable for ECGs with paced rhythms.
Building Out the Cardiovascular Suite
Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus, said the clearance fits into a broader push to use AI to surface cardiovascular risk earlier.
“Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive,” Fornwalt said.
He added that the company’s goal is to help clinicians identify patients “across the spectrum of cardiovascular disease.”
Tempus operates one of the largest multimodal health data libraries in the world and applies AI across multiple clinical areas, not just cardiology.
The ECG-PH clearance expands a cardiovascular AI product line that now covers three distinct conditions, each using the same familiar 12-lead ECG as the input.
The FDA 510(k) pathway is used for medical devices that are substantially equivalent to already legally marketed devices, making it a common route for software-based diagnostic tools.
Tempus ECG-PH is cleared for use at healthcare facilities on clinical diagnostic ECG recordings.
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