Opportunistic screening tool for osteoporosis nabs FDA clearance
A new artificial intelligence-enabled algorithm that provides opportunistic screening for osteoporosis has just been cleared by the U.S. Food and Drug Administration.
San Francisco, California-based Bunkerhill Health—a biotechnology company specializing in AI health solutions—announced the 510(k) clearance of its Bunkerhill BMD algorithm on Thursday. Bunkerhill BMD was developed to assess bone density using routine CT imaging.
The algorithm, which is approved for adults 30 and older, can be applied to noncontrast abdominal CT scans completed for any clinical indication. It analyzes patients’ vertebral structures to determine whether they may be at increased risk of developing osteoporosis or osteopenia, alerting providers when suspicious findings are identified. This is achieved without the need for additional hardware, calibration, phantoms or radiation exposure.
Untreated osteoporosis is a leading cause of hip fractures in the U.S. These major fractures are associated with a mortality rate of up to 30% and require surgical repair and extensive rehab. When the signs of developing osteoporosis/osteopenia are detected early, treatments are capable of slowing its progression and significantly reducing the risk of major fractures.
However, just a fraction of eligible patients complete recommended DXA bone density exams. As such, experts have been studying new methods to determine patients’ risk using other modalities that are more frequently deployed, such as CT.
Assistant Professor of Radiology and Biomedical Data Science at Stanford University and Co-Director of Clinical AI at Stanford Radiology, Akshay Chaudhari, PhD, believes the FDA’s approval of this new opportunistic AI tool could represent a shift in preventive medicine.
“The ability to assess bone health without additional scans, radiation exposure to patients, and cumbersome manual analysis needed from radiologists represents a paradigm shift in how we think about preventative care,” Chaudhari said in a release. “This algorithm reflects how academic innovation, when paired with thoughtful product development, can deliver tools that are both impactful and scalable.”
“This clearance shows what is possible when academic research translates into real-world tools,” added Louis Blankemeier, a former PhD student at Stanford University who worked with Chaudhari during the technical development of Bunkerhill BMD. “We designed this algorithm to turn routine imaging into an opportunity for early intervention—something that could meaningfully improve outcomes for millions of patients at risk for osteoporosis.”
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.