Cardiovascular

Pulmonary Hypertension AI Notification

Flags signs of high blood pressure in the lung arteries, a condition usually found years late.

3 products cleared under FDA code SAT, from April 5, 2024 to August 21, 2026. Checked September 25, 2026.

Pulmonary hypertension is a textbook case of delayed diagnosis. Symptoms are vague, breathlessness gets blamed on fitness or age, and patients often wait years for the right test.

These products look for the pattern in data a hospital already holds and flag the patient for a proper look.

Years earlier is the entire value. The treatments work better the earlier they start.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
SAT
FDA name for it
Pulmonary Hypertension Machine Learning-Based Notification Software
Rule number
21 CFR 870.2380
Risk class
Class 2
Medical field
Cardiovascular
The FDA's own wording: Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.

Before You Sign Anything

  • Ask who is qualified to act on the flag, because this condition needs specialist confirmation and many systems have a queue.
  • Ask what share of flags are confirmed, and what happens to the rest.

Who Holds the Most Clearances Here

CompanyCleared products
Tempus AI, Inc.1
Anumana, Inc.1
Analytics For Life, Inc.1

Every Cleared Product, Newest First

Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.

ProductCompanyClearedFDA record
Tempus ECG-PH Tempus AI, Inc. August 21, 2026 K253699
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) Anumana, Inc. March 28, 2026 K252360
CorVista System with PH Add-On Analytics For Life, Inc. April 5, 2024 K233666

Other Cardiovascular Device Types

Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.