Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
End of Public Health Emergency Won’t End COVID-19 EUAs
FDA will still be able to issue EUAs for COVID-19 tests after May 11.
A Better Test for Early Detection of Multiple Cancers?
A new method of early, multi-cancer detection could prove more effective for non-invasive screening than other emerging options.
Lab Industry Hit by New Wave of Layoffs
Cost cutting and restructuring has become the order of the day for many lab companies.
Researchers Report First “Routine Clinical Use” of AI for Breast Biopsies
While AI as a diagnostic tool is still years away from regular clinical use, recent research is an important step.
Lab Compliance Will Change When Public Health Emergency Ends
Your current COVID-19 testing arrangements may no longer be compliant on May 11.
Weekly Enforcement Report: Telemedicine Scheme Trend Continues
Most of last week’s healthcare-related actions involved telemedicine in some way, with the lone lab-related case centering on genetic testing.
The 2022 Year in FDA 510(k) Approvals
Roche and Abbott received the most approvals for new lab tests last year.
Lab Companies See Massive Layoffs and Restructuring
Economic volatility and uncertainty is also making a significant impact on merger and acquisition activity in the diagnostics space.
Building an Effective Business Case for Your Lab
An effective business case communicates need, benefit, and risks.
FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.