TAG:
Food and Drug Administration
For IVD Companies, Tariff Refunds May Be a Long Haul
Following the US Supreme Court’s decision declaring certain tariffs illegal, the diagnostics industry has entered a murky period regarding potential refunds. For in vitro diagnostics (IVD) manufacturers who paid these tariffs under policies f…
February 9, 2026, Intelligence: Late-Breaking Lab News
Texas Attorney General Ken Paxton filed a lawsuit against Epic Systems, intensifying scrutiny of how pediatric medical records are controlled and the broader power of dominant electronic health record (EHR) vendors. The suit alleges Epic unlawfully monopolizes the EHR…
FDA Reviews Oncology Companion Diagnostics
CEO SUMMARY: Regulatory attorneys indicate that the FDA’s move to reclassify oncology companion diagnostics to Class II medical devices could speed approvals and reduce costs for submissions. From a business perspective, the proposal could allow clinical laboratories to …
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 …
CURRENT ISSUE
Volume XXXIII, No. 8 – June, 2026
Congress Returns to CLIA Reform with Proposed LDT Framework, and the Newly Filed Enhancing CLIA Act seeks to modernize clinical laboratory regulations. A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States.
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