TAG:
IVD
Lab Stakeholders Discuss PAMA Reform
CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …
News Briefs on Alzheimer’s Detection
FDA-cleared IVD could replace scans There has been a significant amount of activity in recent weeks as it concerns tests to detect Alzheimer’s disease. Clinical labs and neuropathologists will want to keep a cl…
Economic, Tech Changes Drive Lab Concerns
CEO SUMMARY: Uncertainty around tariffs, future regulations, and artificial intelligence (AI) defined the mood at the 2025 Executive War College, where nearly 1,000 lab leaders gathered. Speakers warned of how stagnant healthcare spending could trickle down to labs. Meanwh…
As 23andMe Faces Bankruptcy, Home Testing Shows Warts
HIGH-STAKES DRAMA SURROUNDING 23ANDME’S BANKRUPTCY—including CEO Anne Wojcicki resigning to try to bid for the company she cofounded and state prosecutors urging caution about the data privacy of the company’s customers—brings up a fundamental question regarding d…
BD Will Sell Diagnostics Arm but Retain Vacutainer Brand
LESS THAN TWO MONTHS AFTER ANNOUNCI…
Global IVD Companies Issue Fourth Quarter 2024 Earnings
OVERALL, IN VITRO DIAGNOSTICS (IVD) COMPANIES REPORTED A MIXED BAG of financial results for the quarter ending Dec. 31, 2024, with Becton, Dickinson and Company, Abbott Laboratories, and Siemens Healthineers showing the most momentum based on r…
Global IVD Companies Issue Third Quarter 2024 Earnings
HERE IS A SUMMARY OF THE THIRD QUARTER FINANCIAL PERFORMANCE of t…
November 4, 2024, Intelligence: Late-Breaking Lab News
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
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
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…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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