AI – Duane Morris Life Sciences Law

October 22, 2025 by Duane Morris

Wearables Webinar Series, Part 3: Product Liability and IP Strategies for Wearables

Duane Morris will host the third session of its Wearable Webinars Series, Product Liability and IP Strategies for Wearables, on Tuesday, November 4, 2025, 12:00 p.m. to 12:30 p.m. Eastern.

REGISTER

About the Program

As wearables continue to reshape industries—from healthcare to consumer tech—their legal implications are evolving just as rapidly. This session brings together three Duane Morris attorneys to unpack the challenges and opportunities companies face in this dynamic space. In the final installment of our series on wearable devices, Duane Morris partners will go over:

Product Liability and Wearables – Sean Burke
- The wearable industry challenges traditional legal frameworks, creating uncertainty for companies navigating potential exposure to product liability litigation. Sean Burke will highlight key issues, emerging trends and strategies to mitigate risk.
FDA Oversight of AI and Machine Learning in Medical Devices – Agatha Liu
- Agatha Liu, Ph.D., will cover how wearables with diagnostic, monitoring or therapeutic claims fall under the FDA’s software as a medical device framework, including predetermined change control plans, good machine learning practices and real-world performance monitoring of adaptive algorithms.
Intellectual Property Strategies for Wearables – Jason Luo
- Jason Luo, Ph.D., will discuss patenting trends and strategies, including timing, jurisdictions and portfolio development, patentability requirements for software and AI, and post-allowance strategies and global due diligence.

About the Webinar Series

Over a series of three mini-webinars, Duane Morris attorneys will offer high-level guidance on current FDA regulations, cybersecurity and data privacy, and product liability and IP strategies for wearables.

About the Duane Morris Life Sciences and Medical Technologies Group

As biotech, biopharma and pharma companies develop new therapeutics, aligning legal strategies with development and commercialization goals throughout the extensive process of funding, R&D, clinical trials and market entry is imperative to a company’s strategy, success and growth. We assist clients in developing and implementing strategies to protect and expand their pipeline and maximize the benefit of their products to their target patient population.

February 13, 2025 by Duane Morris

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.

February 12, 2025February 12, 2025 by Duane Morris

FDA Releases Draft AI Guidance – A New Era for Biotech, Diagnostics and Regulatory Compliance

The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism. As AI increasingly permeates these fields, the regulatory landscape is just beginning to take shape—and these proposed guidelines take a step in that direction by raising awareness of important questions about the future of AI innovation in life sciences. For therapeutic, medical device and diagnostics companies—whether already implementing AI or just beginning to explore its potential—the message is clear: The landscape is evolving, and future success will require thoughtful consideration of compliance, patient safety and privacy protection from the earliest stages of AI adoption.

Read the full Alert on the Duane Morris LLP website.