WASHINGTON, May 24 (Xinhua) -- The U.S. Food and Drug Administration gave a green light on Thursday to the marketing of an artificial intelligence (AI) based detection and diagnosis software designed to detect wrist fractures in adult patients.
The OsteoDetect is a computer-aided detection and diagnostic software that uses an artificial intelligence algorithm to analyze two-dimensional X-ray images for signs of distal radius fracture, a common type of wrist fracture.
The software marks the location of the fracture on the image to aid the provider in detection and diagnosis, according to FDA.
"Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions," said Robert Ochs, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.
"This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures," said Ochs.
OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight regions of distal radius fracture during the review of posterior-anterior and medial-lateral X-ray images of adult wrists.
It is intended to be used by clinicians in various settings, including primary care, emergency medicine, urgent care and specialty care, such as orthopedics, according to FDA.
However, FDA warns that it is an adjunct tool and is not intended to replace a clinician's review of the radiograph or his or her clinical judgment.
