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Has Your AI Been Validated?

Has Your AI Been Validated?

by Michael Schubert, PhD | Oct 28, 2024 | Clinical Diagnostics Insider, Emerging Tests-dtet, FDA-dtet

Many artificial intelligence-based medical devices have not undergone clinical validation—but what does this mean for the lab?

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How Do You Solve a Problem Like AI Regulation?

How Do You Solve a Problem Like AI Regulation?

by Oscelle Boye, MBiomed | Oct 28, 2024 | Essential, FDA-lca, Lab Industry Advisor

How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab

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Special Analysis: HIPAA Compliance Risks of AI in the Lab: Trends and Tips

Special Analysis: HIPAA Compliance Risks of AI in the Lab: Trends and Tips

by Rachel Muenz | Oct 25, 2024 | Elite, HIPAA-lca, Lab Industry Advisor

The most common AI compliance risk areas related to data security and patient privacy, and the current regulatory landscape

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Are Current Regulations Keeping Labs from Benefiting from AI?

Are Current Regulations Keeping Labs from Benefiting from AI?

by Rachel Muenz | Oct 7, 2024 | Compliance Perspectives-lca, Essential, Lab Industry Advisor

Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed

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Dx Deals: More than $62 Million Invested in Startup Labs in Recent Weeks

Dx Deals: More than $62 Million Invested in Startup Labs in Recent Weeks

by Ron Shinkman | Oct 1, 2024 | Deals-lir, Essential, Lab Industry Advisor

The rounds of funding to Clarapath, PreciseDx, and Precision Epigenomics come at a time when other M&A activity is seasonally slow

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