www.fdanews.com/articles/205787-active-life-scientifics-bone-score-device-gets-de-novo-approval
Active Life Scientific’s Bone Score Device Gets De Novo Approval
December 15, 2021
Santa Barbara, Calif.-based Active Life Scientific’s Bone Score assessment device has received the FDA’s de novo approval.
The radiation-free assessment uses a novel device called the OsteoProbe to physically measure bone mineral density and structure.
The measurements are quantified on a Bone Material Strength index, providing physicians with information that they can consider when evaluating a patient's bone health.
The Bone Score assessment device earned CE mark certification in 2017.