Regulatory agencies, such as the European Commission and the U.S. Food and Drug Administration, are now permitting electronic instructions for use (eIFUs) to be distributed alongside paper instructions for use (IFUs) for medical devices….
Continue Reading
Revolutionary AI Platform Announcement
The U.S. Food and Drug Administration has officially launched Elsa, a groundbreaking generative FDA AI technology designed to revolutionize how agency employees perform their daily tasks. This innovative platform represents a…
The U.S. Food and Drug Administration on Monday announced the launch of a new generative AI technology that agency leaders said will help its employees do their jobs more efficiently.WHY IT MATTERSThe tool, called…
Continue Reading
This project represents the first systematic assessment of the US Food and Drug Administration’s postmarket surveillance of legally marketed artificial intelligence and machine learning based medical devices. We focus on the Manufacturer and User…
Continue Reading
Major FDA Milestone for Pediatric Care
The U.S. Food and Drug Administration has granted pediatric approval for GE HealthCare’s Optison, marking a significant advancement in pediatric cardiac imaging. This ultrasound enhancing agent will now help…
What You Should Know:
– Teal Health®, a women’s health company dedicated to eliminating cervical cancer, today announced a landmark achievement: the U.S. Food and Drug Administration (FDA) has approved the Teal Wand™, marking it…
Continue Reading
FaceHeart from Taiwan has obtained regulatory approval in the United States for its AI-driven contactless technology for measuring respiratory rate. It obtained a 510(k) clearance from the US Food and Drug Administration for the respiratory…
Continue Reading
The Assistant Secretary for Technology Policy has released an update of guidance documents that healthcare organizations use to assess and optimize the safety of their electronic health record systems. The new 2025 Safety Assurance Factors…
Continue Reading
What You Should Know:
– Dexcom, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for individuals over the age of 18…
Continue Reading
Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s…
Continue Reading
