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.

AdvaMed Releases Updated Code of Ethics, Effective 2020

The Advanced Medical Technology Association (AdvaMed) has published its updated Code of Ethics. The updated code will become effective on January 1, 2020. AdvaMed has also published an overview of changes.

The updated AdvaMed Code now includes “Key Concepts” at the beginning of each section, with visuals, graphics, callout boxes, examples, explanations and FAQs.

The AdvaMed Code provides medical technology companies with guidance on ethical interactions and relationships with healthcare professionals (HCPs) to ensure that medical decisions are based on the best interests of the patient.

Because the medical technology industry is highly divergent, the AdvaMed Code drafters recognize no single compliance program fits each company. Therefore, AdvaMed encourages companies to adopt an “appropriately tailored” ethics and compliance program, accounting for the specific types of risks that apply to their operations. Companies adopting the AdvaMed Code are encouraged to submit to AdvaMed an annual certification stating adoption of the AdvaMed Code and implementation an effective compliance program.

Read the full Duane Morris Alert.

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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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