The U.S. Food and Drug Administration (FDA) approved France’s Gleamer’s fracture detection software “BoneView” on the 2nd (local time).
“Bon View” is a medical software that highlights the area around suspected fractures in X-ray images through AI algorithms and transmits the data to radiologists.
The approval was based on a study conducted by Boston University School of Medicine on 480 fracture patients. According to the study, the sensitivity of fracture detection through “Bon View” has improved by 10.4% compared to the previous one. The radiographic reading time was shortened by 6.3 seconds per patient, and the false negative rate (unread fracture) on X-rays decreased by 29%.
The company said, “Bon View will improve sensitivity and specificity by detecting and locating the entire fracture across the sternum, chest, and lumbar spine, and shorten reading time,” adding, “This will improve the radiation diagnosis process and optimize patient management.”
According to Glimmer, about 30% of annual emergency room visits are traumatic skeletal injuries. In addition, it occurs mainly in the evening and at night, and the resulting diagnosis error rate reaches up to 24%. Through this approval, Glimmer plans to increase its software reliability and enter the U.S. market in earnest.
Currently, Bonview is used in 13 countries around the world. The European Union granted CE certification to Bonview in 2020. Glymer is a French unlisted medical device company that develops a suite of AI solutions for radiation.
Source: Health Korea News (http://www.hkn24.com)