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
Use of a high-sensitivity cardiac troponin test (hs-cTnT) may be able to more quickly determine whether emergency department patients are having…
From - Diagnostic Testing & Emerging Technologies
Whole-genome sequencing (WGS) identifies additional genetic causes of hypertrophic cardiomyopathy (HCM) beyond those identified through targeted…
From - Diagnostic Testing & Emerging Technologies
The noninvasive pigmented lesion assay (PLA; DermTech) reduces costs compared to the current standard of care for diagnostic workup of pigmented skin lesions suggestive of…
From - Diagnostic Testing & Emerging Technologies
Next-generation sequencing improves definitive diagnoses for children with drug-resistant epilepsy, according to a pilot study published online…