- In May 2025, the U.S. Food and Drug Administration (FDA) released updated draft guidance on Artificial Intelligence-Enabled Device Software Functions, which directly impacts the SaMD sector. This guidance introduces a Predetermined Change Control Plan (PCCP), allowing manufacturers to proactively manage algorithm updates post-market. This move signifies regulatory adaptability in line with the dynamic nature of AI-powered SaMDs and aims to accelerate innovation while maintaining safety and efficacy standards
- In February 2025, Biofourmis, a U.S.-based healthtech company, announced the expansion of its FDA-cleared SaMD platform for heart failure remote monitoring to European markets, following CE certification. The company’s AI-driven solution allows real-time patient insights and has demonstrated reduction in hospital readmissions, offering significant value in post-acute and chronic care
- In January 2025, Digital Diagnostics Inc. launched its new SaMD-based autonomous diagnostic platform for diabetic retinopathy screening in primary care settings. Approved by the FDA and now expanding into Asia-Pacific, this tool eliminates the need for specialist intervention at initial diagnosis, addressing accessibility gaps in vision care
- In March 2024, Siemens Healthineers announced a strategic partnership with U.S. hospital networks to implement their AI-powered SaMD imaging platform across radiology departments. This collaboration focuses on real-time decision support for tumor detection and stroke management, enhancing diagnostic accuracy and workflow efficiency
