The FDA has approved a new artificial intelligence tool called OsteoDetect that helps doctors diagnose wrist fractures. The tool is a computer-aided detection and diagnosis software application that uses AI algorithms to help healthcare providers determine if a wrist fracture is present at a faster rate than traditional diagnostic technologies. The FDA has increasingly approved new technologies that offer novel ways to diagnose and support healthcare providers. The new OsteoDetect approval is the latest example of the FDA's increased acceptance of new technologies, this one specifically targeted at diagnostics. The software works by using AI to analyze 2D x-ray images of the patient's wrist.
The U.S. Food and Drug Administration (FDA) has just approved an AI-based diagnostic tool that can accurately detect wrist fractures. Imagene's OsteoDetect uses machine learning algorithms to study 2D X-rays for the signs of wrist fractures. "Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions," said Robert Ochs, Ph.D., 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." OsteoDetect isn't about to replace doctors but it can help improve fracture detection and get the correct diagnosis and treatment quickly.
The Food and Drug Administration recently approved a software algorithm that helps doctors identify hand fractures in X-rays. On its own, it's not ground-breaking news, but it is a sign artificial intelligence in medicine is getting closer to making regular rounds. In addition to finding new health care veins to mine, AI developers also need operate within the business world of health care and meet basic requirements such as cost-effectiveness. On May 24, FDA gave the green light to market Imagen OsteoDetect, an AI algorithm that uses machine learning techniques to analyze wrist radiographs (X-ray images) to assist clinicians in locating areas of distal radius fracturing. It's designed to be used in a variety of settings, including primary care, emergency medicine, urgent care and specialized care such as orthopedics, FDA said.
The FDA has been approving its fair share of AI-powered medical technology, but its latest might be particularly helpful if you ever have a nasty fall. The agency has greenlit Imagen's OsteoDetect, an AI-based diagnostic tool that can quickly detect distal radius wrist fractures. Its machine learning algorithm studies 2D X-rays for the telltale signs of fractures and marks them for closer study. It's not a replacement for doctors or clinicians, the 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."
In an ongoing effort to get more AI into healthcare, the FDA just approved the marketing of an algorithm that detects wrist fractures. The news: The software, called OsteoDetect, identifies fractures in x-rays. Two different studies by Imagen Tech, the company that makes it, showed that it made orthopedic hand surgeons better at spotting fractures. Background: This isn't the first AI to get the green light from the FDA. This year the agency has given the go-ahead for an AI that diagnoses a certain kind of eye disease, and another that helps detect strokes.
In a continued focus on improving digital health technology, the United States Food and Drug Administration has permitted marketing of an artificial intelligence (AI)-based algorithm for detection of wrist fractures. The software, known as OsteoDetect, effectively identifies distal radius fractures in two-dimensional X-ray images. The device is intended as an adjunct and not a replacement for clinician review of radiographs, the FDA noted. In retrospective studies submitted to the FDA for the approval, use of the device increased sensitivity and specificity as well as both positive and negative predictive values when compared with standard methods. "Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions," said Robert Ochs, PhD, the acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, in a statement.
The Food and Drug Administration has cleared new computer-aided detection and diagnosis software that uses an artificial intelligence algorithm to analyze X-ray images to detect wrist fractures in adult patients. The OsteoDetect software from Imagen Technologies, which was reviewed through the De Novo premarket regulatory pathway for low to moderate risk devices, analyzes wrist radiographs using machine learning techniques to identify and highlight regions of distal radius fracture--a common type of wrist fracture--to aid detection and diagnosis. "Artificial intelligence algorithms have tremendous potential to help healthcare 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." According to the FDA, the software is "intended to be used by clinicians in various settings, including primary care, emergency medicine, urgent care and specialty care, such as orthopedics."