Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
European Commission accuses sequencing giant of “jumping the gun” on Grail acquisition.
While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.