Oh cool. Is this just how it is now?
US-based researchers found that just three of the 1357 AI-based medical devices registered by the Food and Drugs Administration had been tested on whether they could improve patient health.
To which this Back Page scribe says: cool. Okay. Good to know.
Even AI’s biggest proponents admit they are “a little bit scared” of it, so why would we need to take extra steps to ensure it was safe for medicine, right guys? Right?
The study itself was a systematic analysis of all the AI-enabled medical devices cleared by the FDA as of December 2025.
To be approved by the FDA, medical device manufacturers only needed to demonstrate a “substantial equivalence” to an existing approved device.
According to the research, which was published in PLOS Digital Health, this “[allowed] evidence gaps to propagate through chains of predicate devices” and had created a paradox in which the market was crowded with AI tools which lacked evidence of patient efficacy.
The vast majority – 78% – of the devices were for use in radiology. A further 9% were marketed toward cardiovascular physicians, and 5% were intended for use in neurology.
Researchers made reference to several high-profile AI medical device failures, including the Epic Sepsis Model, which missed two thirds of patients with sepsis while generating alerts for nearly one in five admitted patients.
“Regulatory clearance has far outpaced clinical validation, creating an ecosystem where innovation advances without accountability and patients bear the risks of unproven technologies,” the researchers wrote in PLOS Digital Health.
“Among 1,357 cleared devices, only three have been evaluated for patient-centered outcomes such as mortality, morbidity, or readmissions, and even these studies relied on modest sample sizes and limited geographic diversity.”
While this specific study was confined to medical devices in the United States, the research team pointed out that other countries had traditionally* treated FDA approval as a “de facto passport” for the international commercialisation of AI medical devices.
*In the last few years, maybe not so much.
Test your AI-powered medical device by sending story tips to Holly@medicalrepublic.com.au.
