More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
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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.
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.