FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
In both cases, the diagnostic tests report results back within 15 minutes
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
Whether the MiniDraw™ device dredges up memories of Theranos’ failed tech remains to be seen.
First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
Rachel Rangel, AuD, discusses a new toolkit to help laboratory professionals ensure diversity and inclusion is addressed in their research.
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
