Hypertension AI Notification
Flags patterns suggesting high blood pressure that has not been picked up or is not controlled.
High blood pressure is the most common treatable condition in the world, and a large share of people who have it either do not know or are not controlled.
Software in this device type looks for the pattern in existing data and prompts a clinician.
The clinical problem here is not diagnosis. Anyone can diagnose high blood pressure with a cuff. The problem is that nobody followed up, and this device type aims squarely at that gap.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- SFR
- FDA name for it
- Hypertension Machine Learning-Based Notification Software
- Rule number
- 21 CFR 870.2380
- Risk class
- Class 2
- Medical field
- Cardiovascular
Before You Sign Anything
- Ask how it avoids flagging patients you already know about and are already treating.
- Ask what the follow-up load looks like in a clinic your size before you turn it on.
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.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| Hypertension Notification Feature (HTNF) | Apple, Inc. | September 11, 2025 | K250507 |
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.