FDA AI enabled medical devices top 1,500 authorisations

The Food and Drug Administration (FDA) has now authorised more than 1,500 AI enabled devices, MedTech Dive reported. An editor's note from the publication describes how the technology is spreading through the sector. Many of the FDA AI enabled medical devices won authorisation in just the past several years.

What AI has changed

Artificial intelligence is taking off across the medical device industry. It has changed what counts as a medical device, and it is carrying medtech into new areas.

Developers now use AI to detect health conditions such as sepsis. Other tools identify heart health problems.

A first for breast cancer risk

In June 2025, the FDA authorised the first AI tool to predict a patient's five year breast cancer risk from a routine mammogram. Clairity made the tool.

AI that detects breast cancer has been in use for decades. Those tools look for disease that may already be present. The Clairity tool is the first to forecast future risk instead.

Foundation models and generative AI

Use of the technology keeps moving quickly as it becomes more common. Foundation models are one example. They have drawn device makers such as GE HealthCare and Aidoc, as well as technology groups such as Nvidia and Amazon Web Services.

Medtech companies have also begun to look at generative AI as a way to build new products and technologies. The FDA has not yet made clear its approach to regulating generative AI.

Questions that follow

The growing role of AI in medtech raises several questions. Companies and regulators must determine how to deploy tools effectively and test them for safety and bias. They must also settle how rules should apply to the technology.

Where the editor's note points

MedTech Dive presents the note as the opening to a collection of its stories on how AI is changing the medtech space.

Why it matters

FDA AI enabled medical devices are now a large and growing category, while the rules for generative tools remain unsettled and authorisations keep arriving. Medigear.uk follows FDA AI enabled medical devices and wider medtech AI news.

Source: MedTech Dive