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Center for Devices and Radiological Health
FDA Issues Memo to Reclassify Many High Risk IVD Assays
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
FDA & CMS Issue Letter, Agree on LDT Oversight
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…
November 13, 2023, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXX, Number 16 – November 13, 2023 Issue
Federal regulators recently confirmed that Dec. 4 remains the deadline for public comment on the proposed rule that the federal Food and Drug Administration (FDA) would use to regulate laboratory developed tests (LDTs). This was confirmed during a public webinar for the lab and in vi…
March 6, 2023, Intelligence: Late-Breaking Lab News
By Scott Wallask | From the Volume XXX No. 4 – March 6, 2023 Issue
Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agencyâs oversight of LDTs. âWe are moving forward with rulemaking,â said Eliza…
Paigeâs Digital AI Tool Aids in Prostate Cancer Diagnosis
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
CEO SUMMARY: Study data provided to the FDA âdemonstrated increased diagnostic accuracyâ when pathologists used the Paige Prostate system, said Paigeâs Medical Director. The artificial intelligence-powered pathology image analysis tool is trained to help pathologists detect ev…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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