Canadian AI software developer 16 Bit has received de novo approval from the U.S. Food and Drug Administration (FDA) for Rho, an AI tool for evaluating low bone mineral density (BMD).
Rho uses patented AI technology to automatically scan standard x-rays (frontal projections of the chest, thoracic spine, lumbar spine, pelvis, knee, and hand/wrist) for markers of low BMD, an indicator of osteoporosis, 16 Bit said.
The software could improve screening for osteoporosis, as screening rates using dual energy x-ray absorptiometry scans are low in the U.S., the company noted.
