FDA Publishes Updated List With 521 Authorized AI/ML Enabled Devices

Since 1995, the FDA has authorized more than 500 AI/ML-enabled medical devices via 510(k) clearance, granted De Novo request, or approved PMA. This week the FDA published an updated list with 178 new devices that were authorized through July 2022. According to the FDA, their list is based on publicly available information and is not a comprehensive resource of FDA approved AI/ML-enabled medical devices. In today's DeepTech newsletter I'm sharing a high level analysis of the 521 devices on the list, charts to visualize the data, and a summary of milestones. Note: According to the FDA their list is based on publicly available information and is not a comprehensive resource of approved AI/ML-enabled medical devices.