Thermo Fisher Launches Software for Mass Spectrometry and Chromatography Data
The Chromeleon 7.4 platform consolidates single quad, triple quad, and high-resolution accurate mass analysis workflows into an enterprise-ready system.
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Search Results for: compliance
FDA Issues Finalized Guidance on Emergency Use of Unapproved Diagnostic Tests
The guidance establishes a formal framework for how the FDA will exercise enforcement discretion regarding unapproved diagnostic tests in the event of future public health emergencies.
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Next-Gen Lab Notebook Integrates Agentic Technology
The tech moves beyond traditional record-keeping to actively participate in experiment planning, design, and analysis.
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FDA Withdraws Final Rule Regulating Lab-Developed Tests as Medical Devices
The action follows a federal court order that vacated the 2024 rule, reinstating FDA’s prior policy of enforcement discretion for laboratory-developed tests.
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AdvaMed Calls for Diagnostic Tests to Be Included in Breakthrough Coverage Bill
AdvaMed urges inclusion of diagnostic tests in legislation that would provide four years of coverage for FDA-designated breakthrough technologies.
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