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# AI Software Authorized for Osteoporosis Screens
- URL: https://www.fdaweb.com/ai-software-authorized-for-osteoporosis-screens/
- Published: 2024-04-12T12:00:00.000Z
- Updated: 2026-09-14T14:28:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156767

FDA has granted 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis screening. The device was given a breakthrough device designation in 2021 as the first FDA-recognized radiology software for opportunistic evaluation of low bone mineral density (BMD), according to the company.

Typically, radiologists can only detect bone loss from x-rays when the disease is pronounced, 16 Bit says. “Rho leverages a patented artificial intelligence approach to identify bone loss at a much earlier stage,” it explains. “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.”