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 candidate drug that shows potential—a process that, in and of itself, can take ...
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 ...
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 ...
Medical Device and Diagnostic Industry (MD+DI)

Medical Device Companies Must Navigate Historic FDA Rule Change

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
News Medical

The Role of Process Validation in Ensuring Consistent Drug Quality

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...