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Medical Devices

Overview

We partner with medical device manufacturers in the U.S. and abroad to bring revolutionary products to market, navigate industry regulations, protect designs, drive business growth, and enhance and execute overall business strategies. Our regulatory counsel team manages interactions with governmental agencies, including the Centers for Medicaid and Medicare Services and the Food and Drug Administration, and our government affairs professionals help to identify and mobilize strategies for prompt product approvals and to respond to the challenges and capitalize on the opportunities presented by new regulations and changes in the marketplace. Whether developing a new product, seeking to enter a new market or pursuing a strategic acquisition or affiliation, our regulatory, corporate, transactional and IP attorneys leverage industry-specific insights to help medical device companies advance their goals.

Insights & Events

Latest

Published Articles November 2025

Navigating FDA Regulatory and Litigation Risks With Al-Enabled Medical Devices and Non-Device Software: A Landscape Analysis for Medical Product Counsel

Defense Research Institute’s For the Defense
1 min read
Updates November 2025

The European Union’s Digital Omnibus and Its Impact on Artificial Intelligence

Significant Proposed Changes to Legislation Covering AI, Data Privacy and Cybersecurity
7 min read
Updates November 2025

Potential Challenges to State AI Laws; Senate Hearing on AI; and More Developments

Artificial Intelligence Briefing
6 min read
News November 2025

Faegre Drinker Wins Trial for Surmodics in High-Profile Merger Challenge Against FTC

3 min read
Updates November 2025

SCOTUS Weighs Trump Administration’s Tariff Authority Under IEEPA; Pharma and Device AI; and More

Biopharma & Medical Devices Briefing
7 min read
Updates October 2025

FDA Requests Public Comment on Metrics and Methods for Evaluating Performance of AI-Driven Medical Devices Deployed in Clinical Settings

Written Responses Due by December 1, 2025
3 min read
Updates August 2025

The EU Data Act: Impact on Connected Products and Device Manufacturers

Any Organisation Established Outside the EU but Operating in the EU Market Will Potentially Fall Within Scope
14 min read
Press Release July 2025

Faegre Drinker Continues Product Liability Growth in New York, Adding Counsel Alena Markley

2 min read
Speaking Engagement Recap May 16, 2025

AI Policy and the New Administration: Implications for FDA-Regulated Industries

2025 FDLI Annual Conference
1 min read
Speaking Engagement Recap December 12, 2024

ATA’s EDGE 2024 Policy Conference

1 min read
Insights
Published Articles November 2025

Navigating FDA Regulatory and Litigation Risks With Al-Enabled Medical Devices and Non-Device Software: A Landscape Analysis for Medical Product Counsel

Defense Research Institute’s For the Defense
1 min read
Updates November 2025

The European Union’s Digital Omnibus and Its Impact on Artificial Intelligence

Significant Proposed Changes to Legislation Covering AI, Data Privacy and Cybersecurity
7 min read
Updates November 2025

Potential Challenges to State AI Laws; Senate Hearing on AI; and More Developments

Artificial Intelligence Briefing
6 min read
Updates November 2025

SCOTUS Weighs Trump Administration’s Tariff Authority Under IEEPA; Pharma and Device AI; and More

Biopharma & Medical Devices Briefing
7 min read
Updates October 2025

FDA Requests Public Comment on Metrics and Methods for Evaluating Performance of AI-Driven Medical Devices Deployed in Clinical Settings

Written Responses Due by December 1, 2025
3 min read
Updates August 2025

The EU Data Act: Impact on Connected Products and Device Manufacturers

Any Organisation Established Outside the EU but Operating in the EU Market Will Potentially Fall Within Scope
14 min read
Updates August 2025

Effects of the One Big Beautiful Bill Act on Health Care and Pharma; and More

Biopharma & Medical Devices Briefing
7 min read
Media Mentions June 2025

Bench & Bar of Minnesota Highlights New MSBA President Tom Pack’s Approach to Leadership

1 min read
Updates June 2025

Future Damages and Future Injunction May Constitute Double Recovery in Trade Secrets Case

Insulet Corporation v. EO Flow Co., Ltd.
4 min read
Updates May 2025

Is This the Death Knell of Strict Liability Crimes?

The Impact of President Trump’s May 9, 2025, Executive Order on Regulatory Criminal Offenses & FDCA Enforcement
10 min read

Meet The Team

Meet The Full Medical Devices Team