Is the LDT Final Rule a Sword of Damocles?
The LDT final rule has sent shock waves through the clinical diagnostics industry. Should you be worried, and what can you do about it?
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Search Results for: compliance
Indica Labs’ Digital Pathology Platform Gets FDA Clearance
Indica Labs received FDA clearance for HALO AP Dx, an enterprise digital pathology platform for primary diagnosis.
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FDA Announces Final Rule on LDT Regulation
The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act.
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Bruker Expands Clinical Microbiology and Infection Diagnostics Portfolio
Bruker enhanced diagnostic solutions in microbial identification, antimicrobial susceptibility testing, early sepsis diagnostics, and more.
Read MoreWebinar: Elevate Trauma Care with Advanced Coagulation Testing
Join our webinar to learn how aligning clinical and laboratory practices using the Quantra Hemostasis System can dramatically improve management of critical bleeding. Gain insights on viscoelastic testing, rapid identification of acute coagulopathy, and effective team collaboration. Perfect for technicians, lab managers, and healthcare providers.
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