AI powered technology helps wrist fracture detection, as it got FDA approval. The agency has give permission to go ahead with Imagen’s OsteoDetect, an AI-based diagnostic tool.
It can quickly detect distal radius wrist fractures. Its machine learning algorithm studies 2D X-rays for the revealing signs of fractures and marks them for closer study. It’s not a replacement for doctors or clinicians.
FDA stressed rather, it’s to improve their detection and get the right treatment that much sooner. The approval came relatively quickly by using the De Novo premarket review pathway, which streamlines the process for products with “low to moderate risk.”
You may have to wait a while before you see OsteoDetect in use at the family doctor’s office. However, you might see significantly more AI going forward. FDA commissioner Scott Gottlieb recently said his administration was collaborating with experts on a “new regulatory framework.”
“This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures,” stated Robert Ochs, PhD, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Studies showed that the readers’ ability to detect wrist fractures was improved by using the software as evident by greater sensitivity, specificity, and positive and negative predictive values, compared with unaided standard clinical practice.
It could help the government body keep pace with technologies like AI. If that goes forward, algorithmic health care could quickly become ordinary.