TAG:
FDA
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…
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 …
At ADLM 2025, Spotlight Shines on Relationships
CEO SUMMARY: At the ADLM conference, a new industry survey about the dynamic relationship between medical laboratories, physicians, and patients presented a strong argument for labs taking the lead in communicating and being more accessible to their colleagues. A troubleso…
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…
Lab Industry Fallout from CLIAC Termination
CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…
June 23, 2025, Intelligence: Late-Breaking Lab News
Clinical labs that have business in clinical trials involving genetic samples should note that on June 18, the Food and Drug Administration (FDA) ordered a review of new trials that send samples to “hostile countries for genetic engineering.” The FDA mentioned China specifically. Th…
June 2, 2025, Intelligence: Late-Breaking Lab News
Our sibling publication, G2 Intelligence, reported in May about a new Department of Justice (DOJ) memorandum that indicated prosecutors will seek to exercise fairness when deciding how to pursue fraud cases against clinical laboratories and other organizations. The DOJ emphasiz…
CURRENT ISSUE
Volume XXXII, No. 15 – October 27, 2025
The Dark Report examines the momentous decision by the VA to switch accreditors from The Joint Commission to CAP. Also, we analyze retractions in pathology journals to gain insight into scientific fraud.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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