FDA clears bone measurement device to improve bone health
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Active Life Scientific Inc. has received FDA de novo clearance for Bone Score, a new approach to measuring bone and bone tissue, according to a press release.
Bone Score, a radiation-free in-office assessment, is designed to analyze bone mineral density and structure, allowing physicians to better understand a patient’s bone health, according to the release.
“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,” Peter Burks, PhD, CEO of Active Life Scientific Inc., said in the release. “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,” Burks added.