Summary: 16 Bit Inc. has unveiled the FDA-approved Rho, an AI-enhanced software pioneering osteoporosis screening, addressing the escalating prevalence of the condition by facilitating early detection and intervention.

Key Takeways:

  1. FDA Recognition: Rho, developed by 16 Bit Inc., is acknowledged as the first FDA-approved radiology software for evaluating low bone mineral density, signifying a significant milestone in osteoporosis screening.
  2. Public Health Impact: With a large portion of the population experiencing low bone mineral density and increasing rates of osteoporotic fractures, Rho’s approval addresses a pressing public health concern.
  3. Technological Advancement: Rho’s AI-driven capabilities allow for early detection of bone loss, improving diagnostic accuracy and simplifying the screening process, potentially transforming the landscape of osteoporosis diagnosis and intervention.


16 Bit Inc. announces U.S. FDA approval for Rho, an AI-powered software designed to enhance osteoporosis screening. Recognized as a Breakthrough Device by the FDA since March 2021, Rho stands as the first radiology software authorized for evaluating low bone mineral density (BMD).

Osteoporosis: The Silent Threat to Bone Health

Osteoporosis, a condition characterized by gradual bone weakening, often remains undetected until it leads to fractures. With over 53 million Americans aged 50 and above experiencing low BMD, the prevalence of this condition is expected to rise. Shockingly, statistics indicate that one in every two women and one in every four men will suffer an osteoporotic fracture during their lifetime. However, proactive intervention relies on clinicians’ ability to conduct comprehensive fracture risk assessments and prompt referral for BMD evaluations, typically through dual-energy x-ray absorptiometry (DXA) scans.

Rho AI Breakthrough in Osteoporosis Detection

Despite clinical guidelines recommending universal screening for adults over 50 and targeted assessments for high-risk groups, adherence to these guidelines remains inconsistent. Conversely, routine x-rays, often performed for unrelated diagnostic purposes such as pneumonia detection, are limited in detecting bone loss until the disease has progressed. Rho addresses this limitation by utilizing advanced AI algorithms to identify subtle signs of bone loss at earlier stages. By automatically analyzing specific x-ray images, Rho notifies radiologists of potential cases of low BMD, facilitating the diagnostic process without additional imaging or radiation exposure.

Importantly, interventions extend beyond pharmacological treatments to encompass lifestyle modifications and non-pharmacological therapies. Despite projections of rising economic burdens associated with osteoporosis-related expenditures, the introduction of innovative screening tools like Rho, alongside effective therapeutic approaches, holds promise in mitigating this impending crisis.