AI-Powered Medtech: What Companies Need to Know About Regulatory and IP Risks

As the medtech AI market surges toward $615 billion by 2034, companies must navigate complex licensing, regulatory, and intellectual property challenges. Understanding these key issues is essential to unlocking the full potential of AI-driven healthcare innovation.

The global market value for medical technology utilizing artificial intelligence (AI) is projected to reach about $615 billion by 2034.

According to recent market reports, the global market value for medical technology utilizing artificial intelligence (AI) was estimated to be around $19 billion in 2023, with projections for significant growth to reach about $615 billion by 2034, a compound annual growth rate of over 35%.

The medtech AI market is experiencing a remarkable surge in adoption, driven by advancements in AI algorithms, increasing healthcare data availability, and rising demand for improved diagnostics and treatment options. Factors like personalized medicine, early disease detection, improved patient outcomes, and cost-efficiency are key drivers for the growth of this market. As of August 2024, FDA has authorized 950 artificial intelligence and machine learning (AI/ML) medical devices.

To read the rest of this article by Duane Morris partner Driscoll Ugarte, originally published in MC+CI Qmed, please visit the publication website.

Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq.,
in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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