CoaguSense System Approved in Europe for Self-Monitoring of Oral Anticoagulation Therapy
The Coag-Sense PT/INR Monitoring System gains IVDR approval for home anticoagulation monitoring, marking the company’s European market entry.
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Search Results for: compliance
Clinical Labs Navigate What’s Next After FDA’s LDT Rule Reversal
Greer Massey, PhD, chief scientific officer at Molecular Designs, shares insights on how labs are affected by the rule’s reversal and how they can prepare for future regulatory changes.
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PathAI Expands FDA Clearance for AISight Dx to Support More Slide Scanners
The expansion adds compatibility with Roche’s VENTANA DP 200 and DP 600 scanners and makes AISight Dx the first digital pathology image management system cleared under the FDA’s Predetermined Change Control Plan.
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FDA Issues Notice to Rescind Laboratory Developed Test Rule
The agency signals intent to withdraw final rule extending regulatory authority to LDTs following federal court ruling that vacated the regulation.
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Quanterix Accelerator Laboratory Gains New York State Clinical Lab Permit
The CLIA-certified facility is now authorized to operate in all 50 states, expanding biomarker testing capabilities nationwide.
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