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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.

IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.

CE marking of PromarkerD Hub complements the CE mark that the mass spectrometry version of the test received in November.

The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.

The group wants the agency to allow labs to discuss gene-drug relationships with "adequate evidence" in test reports and hold a public meeting.