The Bone Score™ assessment is a fundamentally new approach to measuring bone.Using groundbreaking technology, the assessment introduces established engineering principals to the field of bone health by enabling physicians to physically test bone tissue at a microscopic level.
Bone Score™, along with other diagnostic tests, helps physicians assemble a more comprehensive understanding of a patient’s bone health.
Active Life Scientific, Inc. (ALSI) 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.
“People are often shocked to learn that bone density is only one part of having strong healthy bones. In fact, most patients who suffer a fracture due to fragile bones do not have osteoporotic bone density,” said Dr. Paul Hansma, a UC Santa Barbara Professor of Physics who invented the technology behind Bone Score™. “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.”
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.