Thursday, April 11, 2024
16 Bit announced that the FDA has given the green light for Rho™ through De Novo marketing authorization. Rho™ is an AI-driven software designed to bridge the gap in osteoporosis screening. This groundbreaking approval follows its recognition as a Breakthrough Device by the FDA in March 2021, making it the first radiology software approved by the FDA for identifying low bone mineral density (BMD) opportunistically.
Osteoporosis is a silent disease that gradually weakens bones, often presenting itself initially through fractures. In the U.S., over 53 million people aged 50 and older have low BMD, a figure expected to rise with the aging population. Shockingly, one in two women and one in four men will suffer an osteoporotic fracture in their lifetime.
Despite recommendations for clinical risk assessments and DXA screening, many individuals at risk go undiagnosed and untreated. Rho™ aims to change this narrative. By utilizing patented AI technology, Rho™ can detect bone loss at earlier stages by analyzing standard x-rays. It automatically scans eligible x-rays, alerting radiologists to potential cases, thus facilitating timely risk assessment without additional imaging or radiation exposure.
This innovative approach aligns with effective preventive and therapeutic strategies, including lifestyle adjustments and pharmacological interventions. With the annual costs associated with osteoporosis projected to rise, solutions like Rho™ offer hope in reducing this burden through improved screening and treatment options.
Source: prnewswire.com
