Active Life Scientific, Inc. (ALSI) today announced it has received U.S. Food and Drug Administration De Novo clearance for its groundbreaking bone measurement device. The Bone Score™ assessment takes a fundamentally new approach to measuring bone and uses innovative technology to physically test bone tissue. It can be used, along with other diagnostic tests, to help physicians assemble a more comprehensive understanding of a patient’s bone health. The recent U.S. clearance follows CE Mark in Europe (obtained in 2017) and marks an important step in expanding tools available to physicians who manage bone health.
“There’s a difference between how much bone you have, or density, and how good your bone tissue is, or quality. Unfortunately, the clinical assessment of quality remains a ‘black box’. The Bone Score™ test quantifies how bone tissue resists a physical challenge, on a safe, microscopic level, and provides previously unavailable data for physicians to consider when investigating the quality of a patient’s bone,’ Dr. Hansma added.
A safe and radiation-free in-office assessment, Bone Score™, is differentiated from other radiological or imaging methods (X-ray, DEXA and CT) that measure bone mineral density and structure. It is a physical method, using a novel device (the OsteoProbe®), that is quantified as Bone Material Strength index (BMSi) or Bone Score™, and provides physicians with previously unavailable information that they can consider, along with other factors, when evaluating a patient’s bone health.
