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# De Novo OK for Osteopenia Device
- URL: https://www.fdaweb.com/de-novo-ok-for-osteopenia-device/
- Published: 2024-01-22T12:00:00.000Z
- Updated: 2026-09-14T14:20:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156181

FDA has granted Bone Health Technologies a *de novo* marketing authorization for its Osteoboost, the first non-pharmacological device-based prescription treatment for postmenopausal women diagnosed with osteopenia (low bone density). The wearable belt is worn on the hips and delivers calibrated vibration to the lumbar spine and hips, the company says. “Osteoboost is indicated to reduce bone strength and density decline in postmenopausal women and is the first and only solution specifically designed to improve bone health during osteopenia,” it adds.

Osteoboost previously received a breakthrough device designation. Its authorization is based on data from an NIH-funded sham-controlled study conducted at the University of Nebraska Medical Center, the company says.

In the study, the primary outcome measurement was the change in vertebral strength measured by CT scan. Those who used the device a minimum of three times per week lost on average 0.48% bone strength, compared with the Sham group who lost 2.84%, Bone Health says.