TAG:
FDA
Despite COVID-19 Losses, IVD Executives Remain Upbeat
Continuing declines in COVID-19 test revenues was a common theme during the first quarte…
Lab Execs Allegedly Lied to FDA about Faulty Tests
CEO SUMMARY: Three former executives of a lab testing company face criminal charges. Federal prosecutors claim that the three plaintiffs who previously worked at Magellan Diagnostics flagrantly hid…
What’s Next in 2023 for Clinical Laboratories?
AS YOU OPEN THIS ISSUE OF THE DARK REPORT, in New Orleans, about 900 senior lab administrators, executives, and pathologists will be gathered at the 28th annual Executive War College on …
OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens
CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…
March 27, 2023, Intelligence: Late-Breaking Lab News
Clinical laboratory leaders watching at-home care evolve should note the new partnership between Best Buy and Atrium Health in Charlotte, North Carolina. As part of the deal, Best Buy Health, a division of the retailer, will assist patients in setting up the technology pieces of …
March 6, 2023, Intelligence: Late-Breaking Lab News
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 agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…
Pandemic Helped Lab with Hospital Leaders
CEO SUMMARY: Growth at Atrium Health during the COVID-19 pandemic elevated its clinical laboratory’s profile with medical leaders and health system administrators. What followed was a new spirit of collaboration that led to lab involvement in cost savings efforts, such as improved…
Public IVD Companies Report Q4, Full-Year 2022 Earnings
YEAR-END AND Q4 EARNINGS REPORTS FROM MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANIES pointed to a welcome sign of core diagnostic business rebounding. That’s the good news for IVD firms. The bad news? All of the SARS-CoV-2 testing revenue that th…
Fujifilm Buys Inspirata’s Digital Pathology Assets
CEO SUMMARY: Fujifilm’s acquisition of the digital pathology technologies and clients of Inspirata marks the departure of one early entrant into the digital pathology market. At the same time, executives from Fujifilm Healthcare Americas Corporation discuss why the company is incr…
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
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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