FRANCE – Gleamer, a French imaging AI company, has received FDA 510(k) clearance for its software, BoneView, designed to detect fractures in X-rays.
Gleamer’s BoneView platform, which previously received a CE mark in Europe, is designed to detect broken bones in the upper and lower extremities as well as in the rib cage and spine.
The company’s CEO and cofounder Christian Allouche said in a statement: “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 Paris-based company stated that its computer-assisted diagnostic system will aid emergency room physicians, orthopedic surgeons, rheumatologists, and family physicians in quickly assessing X-ray images.
When a fracture is detected, Gleamer’s platform prioritizes the report and sends its findings to a radiologist for confirmation.
According to Gleamer, traumatic skeletal injuries are the leading cause of consult requests in hospital emergency rooms, with broken bones accounting for roughly one-third of all annual visits.
According to the company, fracture misinterpretations account for nearly a quarter of diagnostic errors, particularly during evening and overnight shifts.
In a study that collected images from multiple U.S. healthcare centers and specialists using a variety of X-ray machines, BoneView’s AI program demonstrated that it could help reduce the rate of undetected fractures by nearly 30%.
According to the company, the BoneView system is available in the United States not only through Gleamer but also through Fujifilm, Aidoc, Ferrum Health, and Blackford Analysis’ imaging analysis platforms.
Gleamer is also developing ChestView, a program for detecting potentially cancerous lung nodules as well as other thoracic conditions such as pneumothorax and pleural effusion.
AI is being used in imaging by a number of other companies. Sirona Medical raised US$40 million in Series B funding in November after recently acquiring the AI capabilities and some personnel from fellow radiology-focused company Nines.
Qure.ai raised £3.2 million (US$ 4.2million) in funding last month, shortly after receiving FDA approval for an AI algorithm that assists providers in placing breathing tubes using chest X-rays.
The FDA has also approved the company’s head CT scan product. Nanox and Aidoc are two other players in the space.
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