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Pharmaceutical Industry › Algorithms › Medical Devices

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper 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

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

ArentFox Schiff on

Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Epstein Becker & Green

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

Epstein Becker & Green on

This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...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

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

Hogan Lovells

An intelligent approach for regulating medical device AI

Hogan Lovells on

From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more

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