Finnish orthopedic device manufacturer Bone Index said it has won Medicare and Medicaid coverage for its Bindex point-of-care osteoporosis measurement device for ambulatory surgical and outpatient settings.
Bindex measures the cortical bone thickness of the tibia and an algorithm calculates the density index, a parameter that estimates bone mineral density at the hip as measured with a bone-density (DXA) scan. The device detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis, according to the Helsinki-based company. The FDA approved Bindex in January 2017.
“This significant reimbursement coverage is a remarkable milestone for Bindex measurement,” said Bone Index CEO Dr. Ossi Riekkinen in a prepared statement. “Bindex is a new and unique medical device which provides significant improvement in osteoporosis screening and diagnostics in the U.S. Now a large number of healthcare operators are able to provide highly needed osteoporosis examinations. However, we continue our hard work to broaden the coverage landscape to physician offices.”
Undiagnosed osteoporosis is a worldwide challenge, causing more than 8.9 million fractures annually, according to the International Osteoporosis Foundation. In the U.S. alone, osteoporosis is responsible for two million broken bones every year, costing more than $19 billion.
Most bone density scans are performed in hospitals with large, expensive DXA machines, according to Reikkinen. “The overall aim is to prevent osteoporotic fractures, improve surgical outcomes and improve the quality of life for families in the U.S.,” he said.