FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Roche Scores First European IVDR Approval for Diagnostic Tests
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
The Top 10 Most Significant FDA New Lab Test Approvals of 2022
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.
December 2022 FDA Watch: More Approvals in US than EU
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
New EU IV Diagnostic Regulation Set to Roll Out
The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of so-called Notified Bodies.