Cancer is the leading cause of death worldwide, accounting for nearly one in every six deaths. According to a recent paper, an estimated 15% of cancer-related deaths could be avoided by early disease detection.1 However, there are currently very few...
Expertise: Diagnostics 28 results
Women's Health
Charlie Chrisawn
Over the past decade, the development of digital medicines has been steadily gaining momentum, with real-world data demonstrating that these approaches can help improve patient lives. The COVID-19 pandemic further propelled the digital medicines industry forward by shining a light...
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition...
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition...
The In Vitro Diagnostic Regulation (IVDR) has fundamentally changed how in vitro diagnostics (IVD) are regulated in the EU. As a result, scrutiny for review and documentation has increased substantially, including a dramatic increase in required reviews by notified bodies...
Molecular diagnostics can provide a more precise and scientifically sound basis for the practice of medicine. However, barriers to their adoption may increase the risk for developers and delay the practice of precision medicine. With the recent evolution of regulations...
Healthcare payers, regulators, and physicians focus on clinical utility when evaluating molecular diagnostics tests. Clinical validation — establishing that the test can make a diagnosis or predict clinical outcomes — may not be enough to garner acceptance. This point is...