FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
From - Diagnostic Testing & Emerging Technologies
Patients at risk for tuberculosis (TB) infection should be assessed with newer tests, including interferon-gamma release assays (IGRAs) and molecular diagnostics, according to…
From - Diagnostic Testing & Emerging Technologies
A constant refrain within the diagnostics industry is a need for standardization. Rapidly developing technology and testing methods, the call for interoperability, and the vast amount of …
From - Diagnostic Testing & Emerging Technologies
Nonsevere fetal malformations and structural abnormalities are relatively frequent findings of routine, prenatal ultrasounds. Yet, these findings provide…
From - Diagnostic Testing & Emerging Technologies
Despite the commonly held belief that the food allergy prevalence is rising, food allergies remain poorly studied and…
From - Diagnostic Testing & Emerging Technologies
Child–parent hypercholesterolemia (FH) screening is a practical and effective way of conducting population-based screening to identify the…