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Medical Devices › Medical Technology Companies › Food and Drug Administration (FDA)

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Settlement With Medical Technology Company Signals Expanding Cybersecurity FCA Risk for Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on

- What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies. - Why it...more

Akin Gump Strauss Hauer & Feld LLP

FDA Moves Forward on Fluoropolymers

Akin Gump Strauss Hauer & Feld LLP on

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Goodwin

US Emerging as Top Global Medtech Destination

Goodwin on

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Knobbe Martens

Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow

Knobbe Martens on

A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 9

McGuireWoods LLP on

The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable...more

McDermott Will & Schulte

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

McDermott Will & Schulte on

Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

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