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 Alzheimer’s Early Detection Tests Get FDA Green Light
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
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.
Illumina Faces Loss of Grail, Massive Fines
European Commission accuses sequencing giant of “jumping the gun” on Grail acquisition.
New EU IV Diagnostic Regulation Takes Effect on May 26
While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.