LDTs - G2 Intelligence

FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway

FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway

by Glenn S. Demby | Nov 24, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet

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CMS Repeals Rule Providing Expedited Medicare Coverage for MCIT “Breakthrough” Devices

CMS Repeals Rule Providing Expedited Medicare Coverage for MCIT “Breakthrough” Devices

by Glenn S. Demby | Nov 19, 2021 | Articles, CMS-nir, Essential, Must read, National Lab Reporter

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FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway

Management Expert Report Cites Weaknesses in Agency’s EUA Processes

by Glenn S. Demby | Oct 29, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

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Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs

Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs

by Glenn S. Demby | Oct 5, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

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Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices

Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices

by Glenn S. Demby | Sep 23, 2021 | Articles, Essential, National Lab Reporter, Reimbursement-nir

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