FDA 510(k) Clearance for Active Life Scientific Bone Score Measurement Device

By Julie A. Vetalice

FDA 510(k) Clearance for Active Life Scientific Bone Score Measurement Device

Active Life Scientific received FDA De Novo clearance for its Bone Score™ bone assessment. It can be used, along with other diagnostic tests, to help physicians assemble a more comprehensive understanding of a patient's bone health. This U.S. clearance follows a 2017 CE Mark approval.

A radiation-free in-office assessment, Bone Score offers an alternative to radiological or other 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.

"It's been decades since a new measurement method was introduced to the field of osteoporosis, as DEXA and ultrasound technologies have been widely used since the 1990s," said Dr. Peter Burks, the CEO of ALSI. "New clinical tools are desperately needed to understand the health of our bones. Many diseases have a library of measurement tools available, but bone health management remains mostly limited to radiation-based imaging technologies. Physical interaction with bone tissue unlocks a previously unavailable data stream for physicians to consider when evaluating their patients."

Source: ALSI, Inc.

Tags: 510(k) Clearance, Regulatory