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The transition from IVDD to IVDR represents the most significant regulatory change for diagnostic devices in Europe in decades. With extended transition periods now in place, clinical study sponsors face both new challenges and opportunities. Understanding the evolving requirements is essential to staying compliant and keeping studies on track.

The global in vitro diagnostics (IVD) market is evolving rapidly, driven by growing demand for faster, more accessible testing across clinical and consumer settings. As healthcare systems shift toward earlier detection, personalised treatment, and decentralised care, the need for innovative diagnostics has never been greater.

For medical device companies looking to grow globally, expanding into both the US and EU often feels like the logical next step. But many teams quickly learn that what works in one region doesn’t always translate to the other. Despite some similarities, the US and EU operate within different regulatory and commercial frameworks.

GLP-1 receptor agonists are quickly becoming versatile treatments with proven effectiveness in cardiovascular disease, chronic kidney disease, sleep apnea, and Alzheimer’s Disease. Early clinical data suggest they may also help in neurodegeneration, osteoarthritis, and other inflammatory conditions, making this drug class a potential game-changer in metabolic medicine, where specialized CRO support is critical for navigating complex clinical development.

The continuous glucose monitor (CGM) has evolved far beyond its original purpose as a diabetes management tool. Recently, the FDA cleared the first over-the-counter CGM intended for anyone 18 years and older who does not use insulin, including those without diabetes who want to better understand how diet and exercise impact blood sugar levels. This landmark approval has opened new frontiers in personalized medicine, where metabolic insights drive precision health interventions.

Discover strategies and considerations that ahead-of-the-curve medical device research teams are using in their clinical trials.

Discover how harmony between your commercial, regulatory, and clinical development strategies sets your medical device trial up for success.

Discover how tailored recruitment models—fully decentralized, hybrid, or traditional clinical sites—can optimize enrollment speed, data quality, and cost efficiency in your oncology diagnostics trial.

A brief overview of why and how we conduct values interviews at Lindus Health.

Discover how integrating clinical development, regulatory compliance, and commercial strategy from the outset can optimize your clinical trial design and increase your chances of bringing a successful treatment to market.