FDA - G2 Intelligence

FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test

FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test

by Ron Shinkman | Jul 17, 2026 | CLIA-lca, CLIA-nir, Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor

Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate

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New Enhancing CLIA Act: What Lab Directors Need to Know

New Enhancing CLIA Act: What Lab Directors Need to Know

by Scott Wallask | Jun 24, 2026 | CLIA-lca, CLIA-nir, CMS-lca, CMS-lir, CMS-nir, Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor, Legislation-lca, Legislation-lir, Legislation-nir

The proposal seeks to move any future LDT authority away from the FDA

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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests

FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests

by Ron Shinkman | Jun 23, 2026 | Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor

Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence

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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously

FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously

by Ron Shinkman | May 27, 2026 | CMS-lca, CMS-lir, CMS-nir, Essential, FDA-lir, FDA-nir, Lab Industry Advisor, Reimbursement-lca, Reimbursement-lir, Reimbursement-nir

FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices

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FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests

FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests

by Ron Shinkman | Apr 14, 2026 | Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor

In both cases, the diagnostic tests report results back within 15 minutes

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