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Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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