HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
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.
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.