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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Search Results for: compliance
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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Bio-Rad Launches Unity Next Peer QC Software in Asia-Pacific
Cloud-based quality control data management platform aims to reduce costly reruns and streamline QC reporting workflows.
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DocVilla Integrates with AccuReference Medical Lab for Direct EHR Connectivity
The cloud-based EHR platform now offers real-time lab ordering and results delivery, eliminating the need for separate portals or fax-based communication.
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Biolabs International Launches AI-Powered Diagnostic App for Home Testing
The app integrates rapid diagnostic testing, artificial intelligence, and telehealth capabilities, while the company’s decentralized clinical trial platform aims to reduce study costs and improve data collection.
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