How Clinical Teams Are Replacing Firefighting With Future-Proof Monitoring The Silent Efficiency Leak: Why Legacy Systems Fail In 2024, a study of 127 Phase III trials revealed a startling pattern: sponsors using conventional risk-based monitoring detected 62% of...
Medical Device Innovation: A Doctor’s Journey to Transforming Respiratory Care
Maria Artunduaga, MD, MPH, MTM Founder and CEO of Samay In This Podcast: How and why Dr. Artunduaga created her company The challenges she faced while garnering investments Why community and mentorship are crucial The journey to winning the grand prize at Medtech...
AI Medical Devices: Answering Your Burning Questions
As artificial intelligence continues to revolutionize medical device development, the FDA's evolving regulatory framework presents both opportunities and challenges for manufacturers. The recently released guidance on AI/ML-enabled medical devices introduces crucial...
Advanced CT Imaging in Preclinical Research: Pioneering Tomorrow’s Cardiovascular Innovations Today
The evolution of medical device testing demands increasingly sophisticated imaging capabilities. At Veranex, our state-of-the-art CT scanning facilities in Paris and Atlanta combined with the expertise of our people represent the cornerstone of modern preclinical...
Rescue Studies: Salvaging Clinical Trials Through Expert Data Management
When a clinical trial faces data quality challenges, every day counts. Rescue studies have become an increasingly critical component in preserving valuable research and protecting investments in medical device development. But what exactly constitutes a rescue study,...
AI Medical Devices: Your Comprehensive Guide to Development and Documentation
The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers and developers, the path from concept to commercialization demands meticulous attention to regulatory requirements and...
Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide
As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software functions (AI-DSF). In 2024-2025, the agency released two crucial guidance documents that reshape the submission process...
Critical Updates for Medical Device Manufacturers and Healthcare Institutions: Switzerland Aligns with EU IVDR Transitions
Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic alignment ensures regulatory equivalence with EU IVD regulations (2017/746 EC, IVDR) while providing manufacturers...
Testing Medical Devices with Artificial Anatomy Models
Whether you’re a new medtech startups or established strategic, testing new devices against realistic anatomical conditions is crucial for success. Artificial anatomy models for medical device testing offer a practical, cost-effective solution that addresses many...
Five Questions to Ask When Selecting a CRO for Preclinical Studies
Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization Below are a few must-ask questions for medtech companies in the market for a CRO that can perform preclinical studies Are you GLP...