TAG:
FDA
AI Hype in Labs: 6 Tips to Sniff Out the BS
By Scott Wallask | From the Volume XXXII, No. 11 – August 4, 2025 Issue
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
By Scott Wallask | From the Volume XXXII, No. 11 – August 4, 2025 Issue
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
By Scott Wallask | From the Volume XXXII, No. 11 – August 4, 2025 Issue
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
By Janette Wider | From the Volume XXXII, No. 11 – August 4, 2025 Issue
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
By Scott Wallask | From the Volume XXXII, No. 10 – July 14, 2025 Issue
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
By Stephen Beale | From the Volume XXXII, No. 9 – June 23, 2025 Issue
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
By Scott Wallask | From the Volume XXXII, No. 9 – June 23, 2025 Issue
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
By Scott Wallask | From the Volume XXXII, No. 8 – June 2, 2025 Issue
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…
Don’t Pass Up Chance to Steer LDTs, PAMA Reform
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CH…
LDT Oversight May Fall to Congress, CLIA
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
CURRENT ISSUE

Volume XXXII, No. 12 – August 25, 2025
In an exclusive interview, a laboratory industry M&A specialist discusses what’s driving lab outreach sales to national lab companies. Also, The Dark Report analyzes ways in which pathology and clinical labs can profitably partner with pharmaceutical companies.
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