AI Medical Devices Without Clinical Validation Tied to More Recalls: What Patients Need to Know
Artificial intelligence is rapidly entering hospitals and clinics, powering devices that interpret imaging scans, assist with diagnoses, and monitor patient health in real time. While these tools hold enormous promise, a new study in JAMA Health Forum warns that many AI-enabled devices are being cleared for use without clinical validation — and those devices are significantly more likely to be recalled.
Why This Matters for Patient Safety
AI is increasingly trusted in critical areas of patient care. When these devices are rushed to market without real-world testing, the risks fall directly on patients:
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