GLEAMER scores FDA 510(k) for AI-enabled fracture detection

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French imaging AI company GLEAMER scored FDA 510(k) clearance for its software designed to identify fractures in X-rays.

BoneView uses artificial intelligence to detect potential fractures and sends results to radiologists for confirmation. The software received a CE mark in Europe in March 2020.

“In the value-based U.S. healthcare system, providers tell us they want to improve the radiographic diagnostic process which accounts for a huge part of their workload and optimize patient management. We are delighted and proud to offer clinicians and patients BoneView AI for this state-of-the-art advancement in radiology and patient care,” the company’s CEO and cofounder Christian Allouche said in a statement.


Radiologists have shown interest in incorporating AI into their work. According to a 2020 survey published in the Journal of the American College of Radiology, about 30% of respondents said they were currently using the technology in their practice, and another 20% said they plan to purchase the tools in the next one to five years.

GLEAMER is pitching the FDA clearance as a way to limit diagnostic error without overloading radiologists. 

“Radiologists’ workload has doubled in the past two decades, and despite technological progress, they must analyze hundreds more images every day, requiring the readings to be highly reliable,” Dr. Ali Guermazi, PhD, chief of radiology at the VA Boston Healthcare System and leader of the company’s clinical trial for its FDA submission

“The assistance of AI should allow us to improve the specificity of the complementary exams prescribed after the radiography, to avoid delays in care, and to direct patients into the right therapeutic pathway. Our study was focused on fracture diagnosis, and a similar concept can be applied to other diseases and disorders.”


There are a variety of other companies utilizing AI in imaging. Sirona Medical, which recently purchased the AI capabilities and some personnel from fellow radiology-focused company Nines, raised $40 million in Series B funding in November.

Last month, raised £3.2 million in funding, shortly after it received the FDA green light for an AI algorithm that assists providers in placing breathing tubes using chest X-rays. The company has also received FDA clearances for its head CT scan product

Other players in the space include Nanox and Aidoc.

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