In 2024, 107 AI-enabled medical devices received FDA approval, bringing the total number of FDA approved devices to over 950. There’s no question that AI technology is becoming common in medical device development projects, but how are medical device design standards evolving to keep pace? On January 6, 2025, the FDA released […] The post Medical Device Design Standards for AI-Enabled Devices: A Total Product Lifecycle Approach first appeared on Vantage Medtech.
