Medical Xpress

Almost half of FDA-approved AI medical devices are not trained on real patient data, research reveals

Artificial intelligence (AI) has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...

New 'liver-on-a-chip' device could make drug safety testing more reliable

Creating a drug that might help treat or cure a health condition in humans is a long, complex process. After developing a ...
MD&M East

How to Use Surrogate Devices for Validation of Destructive Test Methods for Combination Product Design Verification

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
Healthcare Dive

AI devices with no clinical validation tied to more recalls, study finds

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...
YouTube on MSN

The end of checkbox compliance: Aldo Vidinha on the FDA's quality revolution

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
EurekAlert!

Almost half of FDA-approved AI medical devices are not trained on real patient data

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...