FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
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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.
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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.
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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.
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Illumina Faces Loss of Grail, Massive Fines
European Commission accuses sequencing giant of “jumping the gun” on Grail acquisition.