FDA Approves Abbott's FreeStyle Libre CGMs for Use During Medical Imaging
Key Insights
The FDA has cleared Abbott's FreeStyle Libre 2 (search) and 3 continuous glucose monitors (CGMs) for use during common imaging procedures like X-rays, CT scans, and MRIs.
This approval eliminates the need for patients to remove and discard their sensors before undergoing imaging, ensuring continuous glucose data collection.
Abbott's FreeStyle Libre systems are the first and only patient-applied CGMs approved for use during medical imaging screenings, offering increased convenience and potential cost savings.
The FDA has approved Abbott's FreeStyle Libre 2 (search) and 3 continuous glucose monitors (CGMs) for use during medical imaging procedures, including X-rays, CT scans, and MRIs. This clearance eliminates a significant inconvenience for patients with diabetes (search) who previously had to remove their sensors before undergoing such scans.
With this approval, Abbott's FreeStyle Libre systems become the first and only patient-applied CGMs authorized for use during these common medical imaging screenings. The change allows patients to maintain continuous glucose monitoring without interruption, providing a more complete picture of their glucose levels.
Impact on Patient Care
Dr. Carol Wysham, a clinical professor of medicine at the University of Washington School of Medicine, emphasized the importance of this clearance. "The removal of the imaging contraindication from Abbott’s FreeStyle Libre 2 (search) and 3 systems is a big win for patients, allowing them to keep their sensors on and avoid lost data," she stated. Previously, patients had to remove sensors, resulting in several hours without critical glucose data.
Diabetes (search) Management and Imaging Procedures
Imaging procedures are often a necessary part of diabetes (search) care, as diabetes can lead to various medical complications. Abbott rigorously tested its Libre 2 and 3 sensors to ensure they remained effective after radiologic procedures. The FDA clearance was granted without requiring any changes to the sensor design.
Abbott's Commitment
Dr. Anila Bindal, associate medical director for Abbott’s diabetes (search) care business, highlighted the company's dedication to improving diabetes management. "Continuous glucose monitoring is essential for diabetes management," said Dr. Bindal. "We’ve seen first-hand how consistent use of Libre technology benefits people living with diabetes. This contraindication removal aligns with Abbott’s commitment to provide easy, convenient, and affordable technology for diabetes management."