
Focusing on IVDs can save more lives and billions in costs
With increased focus on improving the quality, efficacy, and cost-effectiveness of lab tests, the IVD industry can drive great value for patients and the economics of the healthcare system.
With increased focus on improving the quality, efficacy, and cost-effectiveness of lab tests, the IVD industry can drive great value for patients and the economics of the healthcare system.
Despite the relative paucity of peer-reviewed studies for IVDs in general, several companies are taking steps to publish their data, which can ultimately lead to positive coverage decisions by payers
In vitro diagnostics, particularly lab-developed tests, designed for precision medicine may be among those impacted the most by risk-based frameworks, both overseas and in the U.S.
A look at the advantages of different engineering models that in vitro diagnostic companies should consider adopting to improve production.
Because in vitro diagnostics are so integral to patient care, particularly for oncology, developers must be aware of how quality and efficacy data pertaining to their device will be used.
In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said, does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]
According to a new EvaluateMedtech report, despite the gloomy 2013 the medtech industry has had so far, by 2018, the industry can expect to rake in $455 billion. In vitro diagnostics are forecasted to stay on top as the highest earning sector, with global sales over $58 billion, with cardiology and diagnostic imaging following closely […]