In March 2022, Rho received FDA Breakthrough Device status, allowing for a more interactive and timely communication with the FDA to support its regulatory submission. Rho meets the criteria to receive Breakthrough Device designation, as it (1) provides more effective diagnosis for an irreversibly debilitating human disease (i.e., osteoporosis), and (2) represents breakthrough technologies (i.e., AI). Rho is not cleared for use in the US and not available for sale. FDA 510(k) is pending.
Osteoporosis and osteoporotic fractures can be life-threatening. Osteoporotic fractures occur most commonly in the hip, spine and wrist. For individuals who sustain a hip fracture, 20-24% die within a year, 33% become dependent or enter a nursing home within one year, and 40% are unable to walk independently. Osteoporosis and osteoporotic fractures can be irreversibly debilitating, as it can cause chronic pain, reduced mobility, and depression.
Rho utilizes a deep convolutional neural network to assign a Rho Score that corresponds to a patient’s likelihood of having low bone mineral density. If Rho detects that a patient likely has low BMD, a Rho Report is sent to PACS. The radiologist can choose to include Rho findings in their report. The referring physician can then conduct a clinical fracture risk assessment, and, if necessary, refer the patient for a DXA. Early identification of risk allows for initiation of prevention or treatment strategies to slow or reverse the loss of bone mineral density.