FDA-cleared AI immunology devices
The FDA's AI-enabled device list has 1 devices whose lead review panel is Immunology, 0.1% of all 1,614 listed devices. They come from 1 companies. The first decision was on April 6, 2017 and the most recent on April 6, 2017.
1AI devices
1Companies
2017First decision
2017-04-06Latest decision
Trend: devices per year
2017
Top companies
Most common product codes
All 1 devices, newest first
Frequently asked questions
How many FDA-cleared AI immunology devices are there?
As of the FDA list updated through June 29, 2026, 1 AI-enabled devices have Immunology as their lead review panel (0.1% of the list).
Which companies have the most AI immunology devices?
23andMe, Inc. (1) have the most AI-enabled immunology devices on the FDA list.
Which year had the most AI immunology authorizations?
2017 had the most, with 1 device.
Which FDA pathways are used for AI immunology devices?
De Novo: 1.
What was the most recent AI immunology device on the list?
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia from 23andMe, Inc. (DEN160026), with a decision dated April 6, 2017.