16 Bit announces FDA De Novo marketing authorization for Rho™

16 Bit Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo marketing authorization for Rho™, an AI-enabled software device aimed at improving a known care gap in osteoporosis screening. Rho received Breakthrough Device designation by the FDA in March 2021, signifying the first FDA-authorized radiology software for opportunistic evaluation of low bone mineral density (BMD).

Osteoporosis is a ‘silent’ disease that progressively weakens bones. It is under-screened and under-diagnosed and often initially presents as a devastating fracture. In the U.S., over 53 million people aged 50 years and over have low BMD – a number that is set to increase as the population ages. One in two women, and one in four men, will suffer an osteoporotic fracture in their lifetime. To intervene prior to a first fracture, a clinician must conduct a fracture risk assessment and, if appropriate, refer a patient for BMD assessment, most commonly performed with a dual energy x-ray absorptiometry (DXA) scan. Recommendations for DXA screening vary by advisory group, but in short, adults over age 50 should have a formal clinical fracture risk assessment, and women aged 65 years and older, and men and younger women who are at increased risk of fracture, should be screened by DXA. Despite recommendations, risk assessment is often not performed, patients are often not screened by DXA, and are often not counselled about fracture prevention.

Conversely, most adults in this age group will undergo a standard x-ray for some indication, such as to rule out pneumonia. By eye, radiologists can only detect bone loss from such x-rays when the disease is pronounced. Rho leverages a patented artificial intelligence approach to identify bone loss at a much earlier stage. It automatically scans eligible x-rays (frontal projections of the chest, thoracic spine, lumbar spine, pelvis, knee, and hand/wrist) and alerts radiologists of patients with possible low BMD. Including this finding in an x-ray report is intended to trigger healthcare providers to perform a clinical fracture risk assessment of patients who would benefit, with no additional imaging time or radiation exposure. Importantly, lifestyle modifications, in addition to both pharmacologic and non-pharmacologic therapies, are effective options for prevention and treatment. Annual osteoporosis-related costs are expected to increase from $57 billion to over $95 billion by 2040, but by improving screening with software such as Rho, in combination with effective treatments, this burden could be decreased.
MB Bureau