The label is the most serious warning the agency can place on pharmaceuticals, denoting substances that carry serious health risks that must be weighed against benefits. CNN was the first to report the news, citing two sources familiar with the matter.
San Diego-based Vektor Medical first secured FDA clearance for the AI-powered technology back in 2021. This updated announcement covers the latest version, which includes atrial flutter mapping and several other new features.
These most recent recalls focus on a series of maintenance issues. In 2024, the FDA advised customers to transition away from the two devices and find alternative treatment options.
Dana Smetherman, MD, CEO of the American College of Radiology, explains resources available through its Data Science Institute to evaluate and validate the quality of imaging algorithms.
The label is the most serious warning the agency can place on pharmaceuticals, denoting substances that carry serious health risks that must be weighed against benefits. CNN was the first to report the news, citing two sources familiar with the matter.