On Thursday, May 24, the FDA approved AI-based wrist fracture detection software. OsteoDetect software uses artificial intelligence to help physicians diagnose faster.
( Nevit Dilmen | Wikimedia Commons )
US Food and Drug Administration Approves Commercialization of Artificial Intelligence Algorithm to Detect Wrist Fracture
FDA Approves AI-Based Wrist Fracture Detection Software
On Thursday, May 24, the agency announced that it had approved an AI OsteoDetect's diagnostic and detection software, which enables physicians to speed up the detection of adult wrist fractures.
The software developed by Imagen Technologies of New York uses artificial intelligence to analyze two X-rays on the wrist and punctate fractures in the distal radius, which is known to be one of the most commonly broken bones in the arm. The software then marks the area on the image for further review by a physician.
"Artificial intelligence algorithms have tremendous potential to help healthcare providers diagnose and treat disease," said Robert Ochs, Deputy Director of Radiological Health, Office of In Vitro Diagnostic and Radiological Health at the Center for Devices and FDA Radiological Health
FDA received approval after review of study results
The FDA provided the diagnostic tool after reviewing the results of a retrospective study by the company. The agency found that the study, which included up to 1
The agency also reviewed results of a separate study that documented the performance of 24 providers used the AI-based software. She concluded that OsteoDetect gives better results when it comes to "sensitivity, specificity, and positive and negative predictive values."
FDA accelerates approvals for AI-based devices and tools
It may take a while for doctors to start using OsteoDetect as a diagnostic tool. However, one could see a more frequent use of artificial intelligence in the field of medicine.
Last month, Scott Gottlieb, the FDA Commissioner, said the agency is working with experts to enact new rules and regulations that would allow regulators to keep pace with technologies such as AI and promote innovation in the field ,
Other FDA Approved AI Devices
OsteoDetect is not the first AI-based tool approved by the FDA this year. Last month, the agency approved a medical device that uses artificial intelligence to diagnose a disease known as retinopathy, which is common in diabetics and can lead to visual impairment.
Earlier this year, the FDA added another AI-based clinical procedure decision support software that analyzes CT scans and helps detect strokes.
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