Imagen received FDA de novo clearance to market OsteoDetect computer-aided software designed to detect and diagnose adult wrist fractures.
OsteoDetect uses an artificial intelligence algorithm to analyze 2-D x-ray images for signs of distal radius fracture, then marks the image. It can be used in a wide range of settings: primary care, ER, urgent and specialty care, and can support early intervention in disease.
Imagen submitted results from retrospective study of 1,000 radiographic images that assessed independent performance of the image analysis algorithm for detecting wrist fractures and the accuracy of the fracture localization of OsteoDetect against the performance of three board-certified hand surgeons. The company also submitted a retrospective study of 200 patient cases reviewed by providers. Both studies demonstrated improved distal fracture detection with use of the software vs. unaided performance.
Imagen was founded in 2015, and has raised ~US $21MM in funding to date.
Other companies that are applying algorithm-based technologies for use in orthopaedics include DePuy Synthes, EnHatch, Numerate, NuVasive, Zebra Medical Vision, etc.
Sources: FDA.gov; FormDs
Imagen received FDA de novo clearance to market OsteoDetect computer-aided software designed to detect and diagnose adult wrist fractures.
OsteoDetect uses an artificial intelligence algorithm to analyze 2-D x-ray images for signs of distal radius fracture, then marks the image. It can be used in a wide range of settings: primary care, ER,...
Imagen received FDA de novo clearance to market OsteoDetect computer-aided software designed to detect and diagnose adult wrist fractures.
OsteoDetect uses an artificial intelligence algorithm to analyze 2-D x-ray images for signs of distal radius fracture, then marks the image. It can be used in a wide range of settings: primary care, ER, urgent and specialty care, and can support early intervention in disease.
Imagen submitted results from retrospective study of 1,000 radiographic images that assessed independent performance of the image analysis algorithm for detecting wrist fractures and the accuracy of the fracture localization of OsteoDetect against the performance of three board-certified hand surgeons. The company also submitted a retrospective study of 200 patient cases reviewed by providers. Both studies demonstrated improved distal fracture detection with use of the software vs. unaided performance.
Imagen was founded in 2015, and has raised ~US $21MM in funding to date.
Other companies that are applying algorithm-based technologies for use in orthopaedics include DePuy Synthes, EnHatch, Numerate, NuVasive, Zebra Medical Vision, etc.
Sources: FDA.gov; FormDs
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.