Newsletter - August 1, 2024
The FDA Would Like to See Lifecycle Management for SaMD products
The primary concerns with the safe and effective use of AI-enabled medical devices are their trustworthiness, fairness, and performance. The FDA proposes a lifecycle management (LCM) approach to better address these concerns. This week, a series of blog posts by the FDA’s office leading review of software medical devices...Read More
FDA Increases AI, ML, and NLP Tools for Surveillance
The FDA has an office dedicated to studying the safety of medications. In its annual report, the Office of Surveillance and Epidemiology (OSE) listed a summary of its activities last year. The most prominent information is the increased use of Artificial Intelligence (AI), Machine Learning (ML), and Natural Language...Read More
The FDA Would Like to See Lifecycle Management for SaMD products
The primary concerns with the safe and effective use of AI-enabled medical devices are their trustworthiness, fairness, and performance. The FDA proposes a lifecycle management (LCM) approach to better address these concerns. This week, a series of blog posts by the FDA’s office leading review of software medical devices...Read More
FDA Increases AI, ML, and NLP Tools for Surveillance
The FDA has an office dedicated to studying the safety of medications. In its annual report, the Office of Surveillance and Epidemiology (OSE) listed a summary of its activities last year. The most prominent information is the increased use of Artificial Intelligence (AI), Machine Learning (ML), and Natural Language...Read More
