News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system

You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers.

You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally every retail product. UPCs make scanning at the cash register possible. Now a similar system is coming to medical devices, including the lab analyzers, reagents, and other products used by medical laboratories and pathology. (more…)

FDA Clears First Mobile Radiology Diagnostic App. Is Digital Pathology Next?

Image quality of wireless device screens may already be good enough for basic digital pathology use

When the U.S. Food and Drug Administration (FDA) recently cleared—for the first time—a mobile application (app) for Radiology Diagnostics, it set the scene for similar mobile apps to gain FDA clearance for use in evaluating digital pathology images.

Both pathologists and clinical laboratory managers are likely to be intrigued with how swiftly mobile computing technology can adapted for use with healthcare images. Earning the honors as the first mobile app to be cleared by the FDA for use with radiology images is the Mobile MIM software, developed by MIM Software, Inc. of Cleveland, Ohio.

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