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.

As part of the G7's health track artificial intelligence (AI) governance workstream 2021, member states committed to the creation of 2 deliverables on the subject of governance: These papers are complementary and should therefore be read in combination to gain a more complete picture of the G7's stance on the governance of AI in health. This paper is the result of a concerted effort by G7 nations to contribute to the creation of harmonised principles for the evaluation of AI/ML-enabled medical devices, and the promotion of their effectiveness, performance, safety and ethicality. A total of 3 working group sessions were held to reach consensus on the content of this paper. The rapid emergence of AI/ML-enabled medical devices provides novel challenges to current regulatory and governance systems, which are based on more traditional forms of Software as a Medical Device (SaMD). Regulators, international standards bodies[footnote 2] and health technology assessors across the world are grappling with how they can provide assurance that AI/ML-enabled medical devices are safe, effective and performant – not just under test conditions but in the real world.

On October 14, 2021, the U.S. Food and Drug Administration ("FDA" or the "Agency") held a virtual workshop entitled, Transparency of Artificial Intelligence ("AI")/Machine Learning ("ML")-enabled Medical Devices. The workshop builds upon previous Agency efforts in the AI/ML space. Back in 2019, FDA issued a discussion paper and request for feedback called, Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device ("SaMD"). To support continued framework development and to increase collaboration and innovation between key stakeholders and specialists, FDA created the Digital Health Center of Excellence in 2020. And, in January 2021, FDA published an AI/ML Action Plan, based, in part, on stakeholder feedback to the 2019 discussion paper.