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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Abbott Warns Customers to Discontinue Use of Certain Blood Analysis Cartridges

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

After 'Difficult' 2019, European IVD Industry Looks Forward to Clarity on Brexit, IVDR in 2020

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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.

Proteomics International Kidney Disease Software Tool CE Marked

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

MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers

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.

Coalition Files Citizen Petition to Stop 'Unlawful' FDA Actions Against PGx Testing

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

Jan 10, 2020

ProciseDx Receives CE Mark for POC Gastrointestinal Disorder Assay

Jan 10, 2020

CareDx Receives CE Mark for AlloSeq cfDNA Kit

Jan 08, 2020

Luminex, Microgenics, Sentinel Diagnostics, Others Get FDA Clearances in December

Jan 08, 2020

Applied BioCode Receives FDA Clearance for Syndromic Respiratory Pathogen Panel

Jan 07, 2020

New European IVDR Guidelines Issued for Cybersecurity

Jan 02, 2020

Personalized Medicine in 2019: Options Increasing But Are They Reaching Patients?

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Jan 02, 2020

Japanese Regulator Approves Foundation Medicine CDx for Roche's Rozlytrek in Lung Cancer

Dec 30, 2019

FDA Approves AstraZeneca's Lynparza, Myriad Genetics' CDx for BRCA-Positive Pancreatic Cancer

Dec 26, 2019

BSI Named Notified Body for IVDR in Netherlands

Dec 20, 2019

FDA Clears Curetis Lower Respiratory Tract Infections Panel

Dec 17, 2019

Cytek Gets Chinese Approval for Flow Cytometry Reagents

Dec 17, 2019

FDA Clears DiaSorin Molecular VZV Test

Dec 17, 2019

Baebies CE Marks System for G6PD Testing

Dec 16, 2019

Roche Applies CE Mark to Zika Screening Test

Dec 16, 2019

Ambry Genetics Gains NYS Approval for Paired RNA, DNA Genetic Test

Dec 13, 2019

EU Group Issues New IVD Guidelines

Dec 12, 2019

PerkinElmer's Muscular Dystrophy Screening Kit Receives FDA Marketing Authorization

Dec 10, 2019

Nanomix Readying Multimarker Sepsis Test for Use at Point of Care

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Dec 10, 2019

Seventh Sense Biosystems Gets FDA Clearance for At-Home Blood Collection Device

Dec 10, 2019

Roche Blood Glucose Monitor App Receives CE Mark