


Breaking Down the FDA’s Draft Guidance on Artificial Intelligence-Enabled Device Software Functions
The FDA’s latest draft guidance addresses how AI-enabled device software should be developed, monitored, and updated. From lifecycle planning to model transparency and cybersecurity, here’s what healthtech and medtech teams need to know to stay compliant and innovative in 2025.





Innovative Startups Revolutionizing Breast Cancer Care: A Focus for Breast Cancer Awareness Month
The Significance of Breast Cancer Awareness MonthOctober marks Breast Cancer Awareness Month, which is a global campaign dedicated to raising awareness regarding one of the most common cancers affecting women







Navigating the Regulatory Landscape: The application of risk management to medical devices according to ISO 14971
In the dynamic world of healthcare, innovation and patient well-being intertwine, which is why the development and deployment of medical devices demands a commitment to safety and efficacy. Ensuring the










