Bone Score, which is a radiation-free in-office assessment, utilises an advanced technology to physically test bone tissue
Active Life Scientific has secured FDA de novo clearance for bone measurement device. (Credit: Nicholas Warrilow from Pixabay)
Active Life Scientific (ALSI) has secured de novo clearance from the US Food and Drug Administration (FDA) for its bone measurement device called Bone Score.
Bone Score, which is a safe and radiation-free in-office assessment, utilises an advanced technology to physically test bone tissue.
Using a novel device called OsteoProbe, the physical method that is quantified as Bone Material Strength index (BMSi) or Bone Score allows physicians to gain previously unavailable information for the assessment of patient’s bone health.
Bone Score is designed for use along with other diagnostic tests to enable physicians assemble a more comprehensive understanding of a patient’s bone health.
ALSI CEO Peter Burks said: “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.
“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.”
In 2017, the company secured CE mark approval for its bone measurement device.
According to the company, Bone Score is differentiated from other radiological or imaging methods such as X-ray, DEXA and CT that measure bone mineral density and structure.
Based in Santa Barbara, California, ALSI has developed a fundamentally new approach for the measurement of bone.
The company develops life science research and measurement tools to quantify physical properties of tissues, thereby helping to avoid an invasive biopsy.