Both countries are inspiring success stories and are positioning themselves to play major roles in the global IVD market in the future.

by: Carl McEvoy

Adapting clinical IVD technologies to the biodefense realm and other nonclinical applications provides ample opportunities for growth. An interview with Paul Kinnon of ZyGEM.

by: Interview by Richard Park

A recently developed technology performs the matrix binding and direct measurement of total hemoglobin, and subsequently of glycated hemoglobin, in a five-minute timeframe.

by: Ralph P. McCroskey and Lowry J. Messenger

The “Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act” (HR 3497) would modernize the U.S. drug and diagnostics evaluation and regulatory network by encouraging the discovery and development of new treatments for the many diseases that have few or no options.

by: Richard Park

FDA issued its guidance for industry and FDA staff titled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” In the guidance document’s introduction, FDA states that it proposes the “downclassification” and exemption from 510(k) requirements of the Class II devices that are the subject of the document because the safety and effectiveness of those devices is sufficiently established.

by: Maureen Kingsley

The Pricewaterhouse Coopers report provides an overview of M&A deal activity in the IVD industry during the past two years and the factors driving it, an assessment of the development of new prospects for early detection testing, and a review of significant events for the development of personalized medicine.

by: Richard Park

Samsung Electronics Company, Ltd., a globally recognizable brand of semiconductor, telecommunication, digital media, and digital convergence technologies based in Seoul, South Korea, has acquired the Nexus division of ITC Nexus Holding Company (ITC), a provider of cardiac point-of-care testing products.

by: Maureen Kingsley

After more than 35 years of industry and FDA device and diagnostic evolution, measuring regulatory effectiveness remains difficult because we still see a moving target in submission reviews and enforcement. (Part 2)