FDA Clears Tempus AI's ECG-PH: Spotting Pulmonary Hypertension From a Standard ECG

On August 24, 2026, Tempus AI (NASDAQ: TEM) announced that the U.S. Food and Drug Administration has granted 510(k) clearance for Tempus ECG-PH, an AI-enabled software device that analyzes standard 12-lead electrocardiograms for signs associated with pulmonary hypertension (PH). It is the third FDA-cleared device in the company’s cardiovascular line, extending a franchise whose premise is simple and increasingly proven: turn the cheapest, most ubiquitous cardiac test in medicine into an early-warning screen for diseases that normally demand expensive or invasive workups.

What the device actually does

Tempus ECG-PH analyzes resting, non-ambulatory 12-lead ECG recordings collected at a healthcare facility. The target population is narrow by design: 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 algorithm looks for patterns in the ECG waveform that humans cannot reliably see, and returns a binary flag when it detects signs associated with elevated mean pulmonary artery pressure (mPAP > 20 mmHg), the hemodynamic threshold that indicates pulmonary hypertension.

The labeling 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 run on ECGs with paced rhythms. Results must be interpreted alongside the original ECG trace, the patient’s symptoms, other tests, and clinical history. In practice this is a triage tool for symptomatic patients at the point of care — a nudge toward echocardiography and right heart catheterization, not a replacement for them.

Why pulmonary hypertension needs it

Pulmonary hypertension — stiffening and narrowing of the blood vessels in the lungs, which progressively strains the right side of the heart — is a classic underdiagnosis problem. According to a 2016 study in The Lancet Respiratory Medicine cited in the announcement, PH affects roughly 1% of the global population and up to 10% of adults over 65. Early symptoms are non-specific (breathlessness, fatigue), and the gold-standard diagnostic — right heart catheterization — is invasive enough that nobody orders it speculatively. The result is a disease that is historically found late, often after irreversible damage to the heart’s right ventricle.

“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.”

Because more than 100 million ECGs are performed every year in the United States alone, a subtle AI-readable signature of elevated pulmonary pressure embedded in routine ECG machinery represents screening capacity at a scale no dedicated PH testing program could match.

The third clearance in a deliberate franchise

Tempus has been assembling this cardiac AI suite piece by piece:

• July 2024 — Tempus ECG-AF: flags patients at increased risk of atrial fibrillation. Tempus described it as the first FDA clearance for an AF indication in the category of cardiovascular machine learning-based notification software.
• December 2024 — reimbursement win: CMS assigned procedure codes CPT 0764T and 0765T for assessments with assistive algorithms like ECG-AF to a hospital-outpatient payment category carrying a Medicare rate of $128.90 per assessment, effective January 1, 2025. A cleared algorithm with no payment pathway is software nobody bills for; this was the gate that made the line commercial.
• July 2025 — Tempus ECG-Low EF: detects signs associated with left ventricular ejection fraction at or below 40% in patients 40 and older at risk of heart failure.
• August 2026 — Tempus ECG-PH: today’s clearance, extending the same pattern to the pulmonary vasculature.

The franchise logic is consistent: each algorithm rides on ECGs hospitals already perform, adds zero incremental patient burden, and carries a payable Medicare code (or is expected to).

Competitive and commercial caveats

Two honest caveats temper the story.

First, Tempus is not alone in this category. Anumana, an ECG-AI company formed with Mayo Clinic backing, previously secured its own 510(k) clearance for a pulmonary hypertension ECG algorithm. ECG-PH enters a market that already has an incumbent, and differentiation will be fought over integration depth, cardiology workflow tooling, and data-network effects rather than the mere existence of a clearance.

Second, the 510(k) pathway means the FDA found the device substantially equivalent to an existing legally marketed predicate — it is not an approval granted on new evidence of clinical benefit. And critically, the August 24 announcement says nothing about reimbursement, coding, or pricing for ECG-PH. Whether CMS extends the existing payment assignment that covers ECG-AF, or ECG-PH requires its own coding and coverage path, is the outstanding commercial question that will decide how fast this reaches patients.

Where this sits in Tempus’s business

The ECG-AI suite is one product line inside a much larger diagnostics and data operation. In its Q2 2026 results (reported July 30, 2026), Tempus posted total revenue of $382.5 million, up 22% year-over-year — $289.3 million from Diagnostics (oncology testing volume up 31%) and $93.2 million from Data and Applications. GAAP net income was $5.6 million, helped by $98.5 million in unrealized gains on marketable securities, against an operating loss of $75.9 million. The company raised full-year 2026 revenue guidance to $1.595–1.605 billion (~25% growth), guided Adjusted EBITDA to around $65 million, and held $820.7 million in cash and marketable securities as of June 30, 2026.

Tempus does not break out cardiac algorithm revenue. But the per-assessment economics are high-margin by construction — the software rides on tests hospitals already run, at a reference Medicare rate of $128.90 — so the observables to watch are concrete: whether CMS extends payment to ECG-PH, and whether Tempus starts disclosing cardiac algorithm volumes. The next quarterly report covers the quarter ending September 30, 2026.

The bigger picture

The clearance is a small, precise example of where clinical AI is actually earning its keep in 2026: not replacing doctors, but reading signal out of data streams so routine that nobody looks at them twice. An ECG is a century-old test; the insight that its waveform contains traceable signatures of right-heart strain is what machine learning added. With three cleared indications now covering atrial fibrillation risk, low ejection fraction, and pulmonary hypertension, Tempus is betting that the general practitioner’s most ordinary tool can be quietly upgraded into a broad cardiovascular screen — one binary flag at a time.