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Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs

What happened

Tempus AI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI-enabled software device, ECG-PH, which analyzes electrocardiograms for signs of pulmonary hypertension.

Source

Article excerpt

Highlighted: the sentence this signal was extracted from

ECG-PH clearance adds pulmonary hypertension to Tempus' FDA-cleared AI products for atrial fibrillation and low ejection fraction CHICAGO, August 24, 2026 --( BUSINESS WIRE )--Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension. Tempus ECG-PH is the third FDA-cleared device in Tempus' growing cardiovascular portfolio, expanding the company's suite of next-generation AI products aimed at identifying patients at risk for complex cardiac conditions. PH is characterized by stiffening and narrowing of the blood vessels in the lungs, putting strain on the right side of the heart. It affects roughly 1% of the population and up to 10% of adults over 651, yet can be difficult to diagnose. PH diagnosis typically requires right heart catheterization, an invasive procedure, and echocardiography. "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. "This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the...

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Extracted by Autobound

From the Signal API record
Event
Launch

What this signalsA launch often needs new go-to-market and support spend.

Product
Tempus ECG-PH
Takes effect
Aug 24, 2026
Location
Chicago, Illinois, United States

Companies

  • U.S. Food and Drug AdministrationRelated companyfda.gov

The full record

From the Signal API record

Topics and mentions

Product tags

  • future tech
  • medical
  • general technology

Extraction

Confidence
95%
Detected
Aug 24, 2026
signal_type
news
signal_subtype
launches

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This page shows a preview. The full news record in the Signal API and MCP can also have these 8 fields. Some fields are empty for some signals.

Company

  • linkedin_urlValue in the API
  • industriesValue in the API
  • employee_count_lowValue in the API
  • employee_count_highValue in the API
  • revenueValue in the API
  • descriptionValue in the API

Signal

  • signal_nameValue in the API
  • associationValue in the API
Show the full JSONThe record on this page and the API request

GET /v1/signals/01debe92-38bd-3c18-bc72-489e45baaae9 returns this record as JSON. POST /v1/companies/enrich returns every signal for tempus.com.

{
  "signal_id": "01debe92-38bd-3c18-bc72-489e45baaae9",
  "signal_type": "news",
  "signal_subtype": "launches",
  "detected_at": "2026-08-24T12:30:00+00:00",
  "company": {
    "name": "Tempus AI",
    "domain": "tempus.com"
  },
  "data": {
    "url": "https://finance.yahoo.com/healthcare/articles/tempus-receives-fda-clearance-ai-123000246.html",
    "title": "Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs - Yahoo Finance",
    "excerpt": "ECG-PH clearance adds pulmonary hypertension to Tempus' FDA-cleared AI products for atrial fibrillation and low ejection fraction CHICAGO, August 24, 2026 --( BUSINESS WIRE )--Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension. Tempus ECG-PH is the third FDA-cleared device in Tempus' growing cardiovascular portfolio, expanding the company's suite of next-generation AI products aimed at identifying patients at risk for complex cardiac conditions. PH is characterized by stiffening and narrowing of the blood vessels in the lungs, putting strain on the right side of the heart. It affects roughly 1% of the population and up to 10% of adults over 651, yet can be difficult to diagnose. PH diagnosis typically requires right heart catheterization, an invasive procedure, and echocardiography. \"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. \"This third FDA-cleared cardiovascular device reflects our broader goal of using AI to help identify patients across the...",
    "product": "Tempus ECG-PH",
    "summary": "Tempus AI received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI-enabled software device, ECG-PH, which analyzes electrocardiograms for signs of pulmonary hypertension.",
    "location": "Chicago, Illinois, USA",
    "planning": false,
    "image_url": "https://s.yimg.com/lo/mysterio/api/11B5C1CE4C211F0D3F34B3A22B00878B300478E1EAD8177D3DCC8494A8C02D33/subgraphmysterio/resizefill_w1200_h600;quality_80;format_webp/https:%2F%2Fmedia.zenfs.com%2Fen%2Fbusiness-wire.com%2Ff719dd8f2ce08962493bfd3e3d05ae82.jpg",
    "confidence": 0.95,
    "product_data": {
      "name": "Tempus ECG-PH",
      "full_text": "Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device",
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    "product_tags": [
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    "published_at": "2026-08-24T12:30:00Z",
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        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
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    ],
    "effective_date": "2026-08-24",
    "article_sentence": "Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension.",
    "related_company_name": "U.S. Food and Drug Administration",
    "related_company_domain": "fda.gov"
  }
}

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