The Benefits and Considerations of FDA Pre-Submission Meetings Navigating the regulatory landscape for medical devices can be complex and challenging. One invaluable tool to streamline this process is the FDA’s Pre-Submission (Pre-Sub) program. This program offers medical device manufacturers an opportunity to engage in early and constructive dialogue with the FDA, potentially smoothing the path…
On January 29, 2025, IMDRF released a significant document titled “Good Machine Learning Practice for Medical Device Development: Guiding Principles.” This publication outlines ten guiding principles designed to promote the development of safe, effective, and high-quality medical devices that incorporate artificial intelligence (AI) and machine learning (ML) technologies. These principles are intended to be applied…
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance aimed at developers of artificial intelligence (AI)-enabled medical devices. This document offers comprehensive recommendations to ensure the safety and effectiveness of AI-driven devices throughout their entire product lifecycle. The guidance emphasizes the importance of transparency and the mitigation of bias…
Trends & AI Innovations Trends & AI Innovations This year’s RSNA showcased innovations which are bound to transform radiology redefining diagnostic precision, workflow efficiency, and cross-specialty collaboration. From multi-modal diagnostic acceleration to AI-powered workflow orchestration, the event underscored how cutting-edge technologies are breaking down silos, enhancing decision-making, and addressing workforce challenges. As AI adoption continues…
The Rise of AI Solution Orchestrators: Bridging the Gap Between Innovation and Implementation The Rise of AI Solution Orchestrators: Bridging the Gap Between Innovation and Implementation As artificial intelligence continues to transform medical imaging, healthcare providers face an increasingly complex landscape of AI solutions. While these innovations promise to enhance diagnostic accuracy and streamline workflows,…
Multimodal AI Solutions Multimodal AI Solutions As AI adoption in medical imaging accelerates, multi-modal integration is emerging as a game-changer, enhancing diagnostic speed, accuracy, and clinical efficiency. This blog highlights leading AI companies delivering integrated solutions that seamlessly combine automated triage, advanced image analysis, workflow integration, and structured reporting—key aspects that are particularly critical in…
On Dec. 4, 2024, the U.S. Food and Drug Administration (FDA) issued a final guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions.” This guidance provides a framework for manufacturers to proactively plan for modifications to AI-enabled medical devices, ensuring that these updates maintain device safety…
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