TAG:
IVD
Global IVD Companies Issue Third Quarter 2024 Earnings
By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue
HERE IS A SUMMARY OF THE SECOND QUARTER FINANCIAL PERFORMANCE of …
November 4, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue
Artificial intelligence (AI) is coming to the federal Food and Drug Administration (FDA) and the Veterans Administration (VA). Last week, on Oct. 30, the two agencies issued an announcement that they would partner “to launch an interagency testing ground forchealth…
Global IVD Companies Report Second Quarter 2024 Earnings
By Robert Michel | From the Volume XXXI, No. 13 – September 23, 2024 Issue
IN THE SECOND QUARTER OF 2024, in vitro diagnostics (IVD) companies reported solid revenues as well as new tests, analyzers, and automation. Most of the IVD companies boosted diagnostic sales in low single digit amounts. During the earnings calls, financial analysts asked company leade…
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…
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…
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…
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…
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…
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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