2023 Ranking of the World’s Top 13 IVD Corporations

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

BASED ON 2023 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) manufacturers continued to lead the global IVD market just as they did in 2022. They are: Thermo Fisher Scientific, Inc., Roche Holdings, Abbott Laboratories, and Danaher Corporation. Th…

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What Labs with LDTs Must Do to Comply with FDA’s LDT Rule

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…

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July 22, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

Some hospitals failing to comply with the federal price transparency regulation have been fined. The website of CMS.gov lists 15 hospitals and the amount each was fined. On June 6, 2022, the first fines were levied against Northside Hospital of Atlanta ($883,130) and Northsid…

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Global IVD Companies Report First Quarter 2024 Earnings

By Robert Michel | From the Volume XXXI, No. 9 – July 1, 2024 Issue

IN THEIR INITIAL FINANCIAL REPORTING F…

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ACLA President Van Meter Discusses LDT Lawsuit

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…

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How Private Health Insurers May Respond to FDA LDT Regulation

By Virchow | From the Volume XXXI, No. 8 – June 10, 2024 Issue

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Significant Developments Are Shaping Lab Market

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…

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FDA Hosts Webinar to Explain Key Issues with Final LDT Rule

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

  ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…

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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…

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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…

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