What happened
The Food and Drug Administration granted 510(k) clearance to Tempus AI on August 24, 2026, for Tempus ECG-PH, software that analyzes a standard 12-lead electrocardiogram and flags signs associated with pulmonary hypertension. The company announced the clearance the same day, and the news was reported independently by the trade publication Diagnostic and Interventional Cardiology (dicardiology.com).
Tempus ECG-PH is built to detect signs of an elevated mean pulmonary artery pressure above 20 mmHg, which the company describes as an indicator of pulmonary hypertension. Per Tempus's clearance documentation, the software is intended for use on ECGs collected at a healthcare facility from patients age 40 or older who present with cardiovascular symptoms such as dyspnea, fatigue, chest pain or edema, and who do not already have a known history of the condition.
The company was explicit about the tool's limits in its own materials: the output is binary (elevated risk detected or not) and is not a stand-alone diagnostic. Tempus said results are meant to be read alongside the original ECG, the patient's symptoms, other test results and clinical history, not used in place of them.
Why this clearance, why now
Pulmonary hypertension is a condition in which the blood vessels in the lungs stiffen and narrow, straining the right side of the heart. In its announcement, Tempus said the condition affects roughly 1% of the general population and up to 10% of adults older than 65, and that it is frequently missed because early symptoms are non-specific and the gold-standard diagnostic, right heart catheterization, is invasive.
"Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive," Brandon Fornwalt, MD, PhD, Tempus's senior vice president of cardiology, said in the announcement, as reported by dicardiology.com.
Tempus ECG-PH is the third cardiovascular device the company has taken through FDA clearance, following earlier clearances for ECG-based tools that flag atrial fibrillation risk and low ejection fraction. All three products work the same way commercially: they run against ECGs a health system is already collecting, rather than requiring a new test or a new piece of hardware.
Who is affected
The clearance matters first to health systems and cardiology practices that already use Tempus's ECG-AI products, since ECG-PH extends that same workflow rather than introducing a separate one. It also matters to primary care and emergency department settings, where the device's intended population, patients 40 and older presenting with common cardiovascular symptoms, is broad enough that adoption decisions will likely sit with health system informatics and cardiology leadership rather than individual clinicians.
For competing vendors building ECG-based screening tools, the clearance is a data point on what the FDA will accept for this specific use case: a binary risk flag on standard 12-lead ECG data, explicitly bounded by an age and symptom criteria, with clear labeling that it is not a diagnostic on its own.
What is not yet known
Neither Tempus's announcement nor the independent coverage reviewed for this brief disclosed the sensitivity, specificity or predictive value figures the FDA reviewed for this specific cleared version of ECG-PH, nor pricing or a rollout timeline for health systems. A separate, Tempus-sponsored multi-site study of an earlier investigational version of the model reported an AUROC of 0.86 with 92% specificity and 54% sensitivity at one operating point, but that figure describes a research model, not the FDA-cleared product, and this brief does not present it as such.
What happens next
Tempus has not announced a commercial availability date or a list of launch health systems for ECG-PH. Based on the rollout pattern for its two prior cardiovascular clearances, distribution is likely to run through existing Tempus ECG-AI customers first. Confirmation of specific health system adoption, along with any published performance data for the cleared version, would be the next milestones worth tracking.
Sources
- Tempus AI, Inc. "Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs." Press release, August 24, 2026. Republished via BioSpace: https://www.biospace.com/press-releases/tempus-receives-fda-clearance-for-its-ai-product-intended-to-detect-signs-of-pulmonary-hypertension-from-standard-ecgs
- Diagnostic and Interventional Cardiology. "FDA Clears AI Product that Detects Pulmonary Hypertension from Standard ECGs." August 2026. https://www.dicardiology.com/content/fda-clears-ai-product-detects-pulmonary-hypertension-standard-ecgs
- Tempus AI. "ECG-based Machine Learning Model Identifies Patients at High Risk for Incident Pulmonary Hypertension." (research model performance data, cited for context only, explicitly distinguished from the cleared product in the brief). https://www.tempus.com/publications/ecg-based-machine-learning-model-identifies-patients-at-high-risk-for-incident-pulmonary-hypertension/
- PharmaShots. "Tempus AI Secures FDA Clearance for AI-Enabled Pulmonary Hypertension ECG Tool." https://pharmashots.com/35397/tempus-ai-secures-fda-clearance-for-ai-enabled-pulmonary-hypertension-ecg-tool