French medtech company Gleamer has secured approval from the US Food and Drug Administration (FDA) for its BoneView artificial intelligence (AI) software.
The approval enables US healthcare specialists to use the BoneView AI software for the diagnosing of fractures and traumatic injuries on X-rays.
The AI software is developed for use by radiologists, orthopedic surgeons, emergency physicians, rheumatologists, family physicians, and physician assistants to diagnose fractures in their patients.
Approved as a CADe/CADx (computer-assisted detection and diagnosis) device, BoneView identifies fractures in X-ray images and sends them to radiologists for final validation.
According to the company, the software was demonstrated to help identify and localise fractures over the complete appendicular skeleton, rib cage, thoracic and lumbar spine in the US study.
BoneView was also shown to improve the specificity of fracture detection by radiologists and non-radiologists involving multiple anatomical locations, including foot/ankle, knee/leg, hip/pelvis, hand/wrist, elbow/arm, shoulder/clavicle, rib cage, and thoracolumbar spine, said the company.
Gleamer CEO and co-founder Christian Allouche said: “In the value-based U.S. health care 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.”
In March 2020, Gleamer secured CE mark class 2a certification for the BoneView AI software, which is already used in over 300 institutions across 13 countries.
BoneView has studied over three million images across Europe, the Middle East, Asia-Pacific, and North America to date.
