Tempus Clears Third FDA Cardiac Algorithm: Pulmonary Hypertension ECG Test

Tempus AI (TEM ) has received 510(k) clearance from the U.S. Food and Drug Administration for Tempus ECG-PH, an AI-enabled software device that reads standard 12-lead electrocardiograms for signs associated with pulmonary hypertension — the third FDA-cleared algorithm in the company’s cardiovascular line, the company announced on August 24, 2026.

The clearance extends a franchise Tempus has been assembling since mid-2024: software that turns the cheapest, most common cardiac test in medicine into a screening net for conditions that otherwise require expensive or invasive workups. Pulmonary hypertension fits that template exactly. The condition (stiffening and narrowing of the blood vessels in the lungs, which strains the right side of the heart) affects roughly 1% of the population and up to 10% of adults over 65, according to a 2016 study in The Lancet Respiratory Medicine cited in the release. Diagnosis typically requires echocardiography and right heart catheterization, an invasive procedure, and early symptoms are non-specific enough that the disease is historically underdiagnosed.

“Pulmonary hypertension has historically been underdiagnosed because early symptoms are non-specific and gold-standard diagnostics are invasive,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus, in the release. “This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the spectrum of cardiovascular disease.”

What the Clearance Actually Authorizes

The cleared indication is deliberately narrow, and its edges define who the product can be sold to. Tempus ECG-PH analyzes resting, non-ambulatory 12-lead ECG recordings collected at a healthcare facility from patients 40 years of age or older who present with cardiovascular symptoms (dyspnea, fatigue, chest pain, or edema) and who have no known history of pulmonary hypertension. The software detects signs associated with elevated mean pulmonary artery pressure, defined as mPAP greater than 20 mmHg, and returns a binary output.

The release’s own labeling language fences the product in on three sides: it is not a stand-alone diagnostic, it cannot be used for serial patient monitoring, and it cannot be used on ECGs with paced rhythms. Results must be interpreted alongside the original ECG, the patient’s symptoms, other tests, and clinical history. This is a symptomatic-patient triage tool for the point of care, and the 510(k) pathway itself means the FDA found the device substantially equivalent to an existing legally marketed predicate rather than approving it on new evidence of clinical benefit. Tempus is also not alone in this category: Anumana, an ECG-AI company formed with Mayo Clinic backing, previously secured 510(k) clearance for its own pulmonary hypertension algorithm, so ECG-PH enters a cleared-indication market that already has an incumbent.

Clearance Is the First Gate; Reimbursement Is the Second

The commercial history of this product line is the part of the story the clearance release doesn’t tell. Tempus received its first cardiovascular clearance in July 2024, when the FDA cleared Tempus ECG-AF, an algorithm that flags patients at increased risk of atrial fibrillation: what the company described as the first FDA clearance for an AF indication in the category of cardiovascular machine learning-based notification software. But a cleared algorithm with no payment pathway is software nobody bills for. That gate opened later that year: in a December 17, 2024 announcement, Tempus disclosed that the Centers for Medicare and Medicaid Services had assigned the procedure codes for assessments with assistive algorithms like ECG-AF (CPT 0764T and CPT 0765T) to a hospital-outpatient payment category carrying a Medicare rate of $128.90 per assessment, effective January 1, 2025.

The second clearance followed on July 16, 2025, for Tempus ECG-Low EF, which detects signs associated with a left ventricular ejection fraction at or below 40% in patients 40 and older at risk of heart failure. The context for that $128.90 figure is volume: more than 100 million ECGs are performed each year in the United States, per the study Tempus cites in its December 2024 reimbursement announcement. Whether ECG-PH falls under the same CMS payment assignment that covers ECG-AF, or requires its own coding and coverage path, is the outstanding commercial question. The August 24 release announces the clearance and says nothing about reimbursement, coding, or pricing for the new device.

Where the Cardiac Line Sits in the Business

The ECG-AI suite is a product line inside a much larger diagnostics and data operation. In its second-quarter 2026 results, reported on July 30, 2026, Tempus posted total revenue of $382.5 million, up 22% year-over-year — $289.3 million from Diagnostics, where oncology testing volume grew 31%, and $93.2 million from Data and Applications. The quarter produced GAAP net income of $5.6 million, helped by $98.5 million in unrealized gains on marketable securities, against an operating loss of $75.9 million. Tempus raised its full-year 2026 revenue guidance to $1.595 billion to $1.605 billion, roughly 25% growth, with Adjusted EBITDA expected around $65 million, and held $820.7 million in cash and marketable securities as of June 30, 2026. The company does not break out cardiac algorithm revenue within its Diagnostics segment.

The per-assessment economics of the ECG line are high-margin by construction (the software rides on ECGs hospitals already perform, and the reference Medicare rate is $128.90) but the addressable volume depends on deployment across hospital systems and on each algorithm carrying a payable code. With three clearances now in hand covering atrial fibrillation risk, low ejection fraction, and pulmonary hypertension, the near-term observables for the franchise are concrete: whether CMS extends the existing payment assignment to ECG-PH, and whether Tempus discloses cardiac algorithm volumes or per-test revenue in a future quarterly report. The next such report covers the quarter ending September 30, 2026.