TAG:
Food and Drug Administration
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
In 2026, Challenges Can Be Business Opportunities
Looking over The Dark Report’s annual rundown of the most significant clinical laboratory and pathology stories of the past year, the world “tumult” comes to mind. At points during the past year the tumult leaned in the favor of labs, such as a federal …
Pathologists Take Images to the Cloud
CEO SUMMARY: Scaled-up operations, streamlined logistics, and potential cybersecurity benefits all present a valid argument for pathology practices to move their data to the cloud. Digital pathology in particular stands to gain from a cloud-based setup that allows remote v…
FDA Has Future Avenues to LDT Oversight
CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in mode…
Could AI Oversight in Labs Fall Under a CLIA Model?
CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…
Lumea’s Digital Pathology Success Lands It on Inc. 5000
Digital pathology company Lumea was perhaps the most notable entry from the clinical laboratory world to make it onto the Inc. 5000 list of the fastest growing private companies in America in 2025. Lumea placed mid-pack at No. 2,468 …
AI Hype in Labs: 6 Tips to Sniff Out the BS
CEO SUMMARY: In the final entry of our artificial intelligence series, the co-founders of Sample Healthcare discuss how clinical labs can evaluate AI vendors effectively, with an emphasis on assessing technical credentials and quick proofs of concept. Armed with the right …
JAMA Authors Warn LDT Legal Defeat Brings Risk for Labs
CLINICAL LABORATORY AND ANATOMIC PATHOLOGY LEADERS WILL WANT TO NOTE will a recent JAMA Health Forum article that strikes a cautionary tone about the future of laboratory developed test (LDT) regulation. The piece argued that the recent federal court decision…
Fast, $17.5B Deal Lands Waters Corp. in IVD Market
WHEN BECTON DICKINSON (BD) ANNOUNCED ITS INTENT to spin off its in vitro diagnostics (IVD) and life sciences units in February, few observers expected a deal to close just five months later. But now that such an agreement has occurred as of July 14, the buy…
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
CURRENT ISSUE
Volume XXXII, No. 18 – December 29, 2025
The Dark Report reviews its top 10 stories from 2025, from the vacating of the FDA’s LDT rule to the merger of Waters and Becton Dickinson’s biosciences and diagnostics units. Also, a lab outlines its solution to a shortage of histotechnologists, and another story shows how pathologists can become patients’ partners.
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