FDA
AI in Medicine Gets Closer to Making Regular Rounds
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.
New Stroke Technology to Identify Worst Cases Gets FDA Approval
The Lucid Robotic System is aimed at one of the central dilemmas of modern neurology: How to quickly identify patients with the most severe strokes who could benefit from being taken immediately to hospitals that can perform a complex clot-removal procedure, potentially helping to avoid major disability. The Lucid system, manufactured by Neural Analytics Inc. of Los Angeles, combines two technologies. One is a transcranial ultrasound, which shows whether a blood clot is blocking blood flow to the brain. The ultrasound, taken through a kind of natural window into the brain near a person's ear, is combined with the robotic part, which uses artificial intelligence to assess patients by instantaneously comparing them to thousands of earlier images of patients with severe strokes. "The goal is to have this in the ambulance soon," said Thomas G. Devlin, neurology chairman at the Erlanger Health System in Chattanooga.
Inside Trends And Forecast For The $3.9T AI Industry
TORONTO, ON - APRIL 30: Saudi Arabian citizen Humanoid Robot Sophia is seen during the Discovery exhibition on April 30, 2018 in Toronto, Canada. Artificial Intelligence (AI) is nothing if not controversial. Whether the subject of scrutiny behind hair-raising advances in sex robots which was heavily reported the other week or the topic of the latest disgruntled executive voicing opinions about Elon Musk's crusade against AI's perceived perils, all eyes are on this new area in tech. While no one is yet absolutely sure of AI's definitive path, one thing is certain. Value and expenditures pertaining to this area of emerging technology are on a definite upward curve.
For Some Hard-To-Find Tumors, Doctors See Promise In Artificial Intelligence
A team at Johns Hopkins Medicine in Baltimore is developing a tumor-detecting algorithm for detecting pancreatic cancer. But first, they have to train computers to distinguish between organs. A team at Johns Hopkins Medicine in Baltimore is developing a tumor-detecting algorithm for detecting pancreatic cancer. But first, they have to train computers to distinguish between organs. Artificial intelligence, which is bringing us everything from self-driving cars to personalized ads on the web, is also invading the world of medicine.
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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."
FDA approves AI tool for spotting wrist fractures
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."
Another AI-powered device gets the FDA's blessing
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.
FDA Approves AI Algorithm for Wrist Fracture Detection
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.
FDA approves AI algorithm to help detect wrist fractures
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."
Artificial intelligence is evolving fast. Can the FDA keep up?
The Food and Drug Administration has already approved three products this year that use AI to help diagnose health problems, including one Thursday that detects wrist fractures. And some companies, like IBM, have put their products on the market without agency signoff. Try it FREE for 30 days and cancel anytime! STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience. Try it FREE for 30 days!