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Artificial Intelligence Algorithms Manufacturers

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more

Hogan Lovells

AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the EU and U.S.

Hogan Lovells on

Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more

Amundsen Davis LLC

Minimizing Product Liability Risks Caused by AI: Practical Tips for Businesses

Amundsen Davis LLC on

The use of artificial intelligence AI (AI) touches many sectors in the United States, and the business world is no exception. While this exciting development has proven useful for many businesses, it is also a new source of...more

ArentFox Schiff

Global Perspective on Patenting of AI Technologies

ArentFox Schiff on

The rapid advancement of artificial intelligence (AI) technologies is fueling a surge in global patent filings for AI-related innovations, but differences in national patent laws and examination standards for such inventions...more

Robinson+Cole Data Privacy + Security Insider

How AI Can Address Manufacturing Supply Chain Issues

The global market for artificial intelligence (AI) in manufacturing is valued at $3.2 billion in 2023 and is poised to grow to $20.8 billion by 2028. Used wisely, AI can help manufacturers solve many of their most intractable...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Knobbe Martens

AI & the FDA

Knobbe Martens on

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

Gardner Law on

As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Hot Topics in Products Liability Law: Collection and Use of Data is THE Products Liability Issue of the Future

Data is arguably the products liability issue of the future. Dealing with data is often already a critical part of products liability lawsuits, but with the rise of artificial intelligence and automation, product...more

Foley & Lardner LLP

Legal Implications of the ChatGPT Revolution in Manufacturing

Foley & Lardner LLP on

Generative artificial intelligence (AI) models, such as ChatGPT, will widen the gap between the manufacturers who embrace, and profit from, the shift to Smart Manufacturing and the manufacturers who go about “business as...more

Jackson Lewis P.C.

Finding Diverse Talent in the Manufacturing Industry Revisited: A Skillful Scavenger Hunt

Jackson Lewis P.C. on

Even as the U.S. Bureau of Labor Statistics reports increased hiring in the manufacturing industry over the last year, filling certain positions remain a challenge, especially for those that require highly skilled workers....more

Mintz - Health Care Viewpoints

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions

In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

Robins Kaplan LLP on

The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Cozen O'Connor

How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for...

Cozen O'Connor on

In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Under the Hood of Liability in the Age of Self-Driving Vehicles

Self-driving cars and related legal issues have captivated the cybersecurity world as of late. And with good reason. In 2018 we saw the first fatality associated with a self-driving Uber, adding to the growing attention paid...more

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