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Selected category: In vitro diagnostics

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Adapt or perish? Anatomical pathology labs at a tipping point

By Yves Wurmitzer

The anatomical pathology – or histopathology – services sector is projected to grow, but histopathology labs the world over are struggling in the face of shortages in trained pathologists, increasing regulatory pressure, changing reimbursement policies, and shifting paradigms in healthcare. Modernization of this highly conservative field is imperative. What are the key drivers of change in the industry, and how can anatomical pathology labs prepare to embrace the future? Will automation and digitalization offer a solution?

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Navigating the Future of Laboratory Developed Tests - The Impact of New FDA Guidance

By Nicholas Smith

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.

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Reducing risks in IVD instrument development

By Nicholas Smith

The In Vitro Diagnostic (IVD) medical device market is one where new and advanced applications are appearing every day. Equipment expertise and regulations are becoming increasingly complex to the point that a diagnostic company may not be able to keep pace and bring their platform solution to market in a timely manner with the appropriate support level required by the customer.

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