What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
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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.
Key approvals announced in June represented important steps forward for the lab testing industry.
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.