Cardiovascular

Cardiovascular Machine Learning Notification Software

Watches heart data for a pattern and sends an alert, without saying what the pattern means.

2 products cleared under FDA code QXO, from August 3, 2023 to June 8, 2026. Checked September 25, 2026.

The general purpose entry in the cardiovascular family. These products monitor heart data and raise a flag when a learned pattern appears.

Notification is the operative word. The software gets a clinician to look. The clinician decides.

It sounds modest, and in a health system it is not. Most missed heart conditions are not missed because nobody could tell. They are missed because nobody looked at that test again.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
QXO
FDA name for it
Cardiovascular Machine Learning-Based Notification Software
Rule number
21 CFR 870.2380
Risk class
Class 2
Medical field
Cardiovascular
The FDA's own wording: Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.

Before You Sign Anything

  • Ask who receives the alert and what they are expected to do within what time. An alert with no owner is noise.
  • Ask what the alert volume looks like per thousand studies. Alarm fatigue kills these deployments faster than accuracy problems.

Who Holds the Most Clearances Here

CompanyCleared products
Pathwai, Inc.1
Viz. Ai, 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
EchoNext Pathwai, Inc. June 8, 2026 K260332
Viz HCM Viz. Ai, Inc. August 3, 2023 DEN230003

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.