Tempus, 세 번째 FDA 심장 알고리즘 승인: 폐동맥 고혈압 ECG 검사

Tempus AI (TEM )는 미국 식품의약국(FDA)으로부터 Tempus ECG-PH에 대한 510(k) 승인을 받았습니다. 이 AI 기반 소프트웨어 장치는 표준 12리드 심전도를 읽어 폐동맥 고혈압과 관련된 징후를 감지합니다 — 회사의 심혈관 라인에서 세 번째로 FDA 승인을 받은 알고리즘이며, 회사는 2026년 8월 24일에 발표했습니다.

이번 승인은 Tempus가 2024년 중반부터: 소프트웨어가 의학에서 가장 저렴하고 흔한 심장 검사를 비용이 많이 들거나 침습적인 검사가 필요한 질환을 선별하는 네트워크로 전환합니다. 폐동맥 고혈압은 바로 그 모델에 정확히 들어맞습니다. 이 질환(폐의 혈관이 경직되고 좁아져 오른심장을 부담하게 되는 상태)은 인구의 약 1%와 65세 이상 성인의 최대 10%에 영향을 미치며, 이는 발표에서 인용된 2016년 The Lancet Respiratory Medicine 연구에 근거합니다. 진단은 일반적으로 심초음파와 침습적 절차인 우심도 카테터 검사가 필요하며, 초기 증상이 비특이적이어서 과거에 진단이 부족한 경우가 많았습니다.

“폐동맥 고혈압은 초기 증상이 비특이적이고 표준 진단이 침습적이어서 과거에 진단이 부족했습니다,”라고 Tempus의 심장학 수석 부사장인 Brandon Fornwalt 박사(MD, PhD)가 발표에서 말했습니다. “이번 세 번째 FDA 승인 심혈관 장치는 AI를 활용해 심혈관 질환 전 범위에 걸친 환자를 식별하는 우리의 광범위한 목표를 반영합니다.”

승인이 실제로 허용하는 내용

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: Mayo Clinic의 지원을 받은 ECG‑AI 기업 Anumana가 이전에 자체 폐동맥 고혈압 알고리즘에 대해 510(k) 승인을 받았습니다, 따라서 ECG-PH는 이미 기존 업체가 있는 승인된 적응증 시장에 진입하게 됩니다.

승인은 첫 번째 관문; 상환은 두 번째

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 2024년 7월, when FDA가 Tempus ECG-AF를 승인했습니다. This algorithm 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 2024년 12월 17일 발표, 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 2025년 1월 1일.

The second clearance followed on 2025년 7월 16일, 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 2024년 12월 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.

심장 라인이 비즈니스에서 차지하는 위치

The ECG-AI suite is a product line inside a much larger diagnostics and data operation. In its second-quarter 2026 results, reported on 2026년 7월 30일, 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 2026년 6월 30일. 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 2026년 9월 30일.