The First US Study With FDA Cleared Point-of-Care Device to Help Physicians in Diagnosing Osteoporosis was Published in a Respected International Journal
KUOPIO, Finland, August 9, 2016 /PRNewswire/ --
The internationally respected journal Osteoporosis International has published the results of a US validation study* involving the world's first point-of-care diagnostic device for osteoporosis, Bindex®, developed by Bone Index Ltd.
(Logo: http://photos.prnewswire.com/prnh/20160516/367776LOGO )
Earlier this year Bone Index Ltd., one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the Bindex® point-of-care instrument to help in osteoporosis diagnosis.
In the study, 555 post-menopausal women aged over 50 were tested for bone mineral density. The study showed that about 70% of the women could have been reliably diagnosed in primary health care with the Bindex device and only 30% would have required further assessment by means of an X-ray-based DXA scan in a hospital. According to the study, the Bindex test can be used as an initial screening test for hip osteoporosis and can be recommended for use in primary health care.
Osteoporosis, a very underdiagnosed disease, is responsible for two million broken bones every year in the USA. These fractures translate into costs totaling about 19 billion dollars. Experts forecast that by 2025, the costs due to fractures will rise to 25.3 billion dollars. Currently, one of the biggest challenges in osteoporosis management is the low availability of diagnostics since bone density scans are mostly performed in hospitals with large DXA X-ray machines that entail high costs.
"The article shows well how the Bindex test can be used as an initial screening test for hip osteoporosis. In addition, an interesting finding was that cortical bone thickness measured with Bindex was significantly associated with radiographically confirmed prior fractures, independent of bone mineral density measured with DXA. This highlights the importance of cortical bone properties in osteoporosis," says Dr.John Schousboe, MD, past President of International Society of Clinical Densitometry.
For more information: Bone Index Ltd., Dr. Ossi Riekkinen, CEO, firstname.lastname@example.org, +358-50-363-2797, http://www.bindex.fi/en/
Dr. John Schousboe, MD, Rheumatologist, Director, Park Nicollet Osteoporosis Center, email@example.com
Founded in 2011 and based in Kuopio, Bone Index Finland Ltd. specializes in the development of measuring devices for osteoporosis screening and diagnosis.
* Schousboe et al. "Prediction of Hip Osteoporosis by DXA Using a Novel Pulse-Echo Ultrasound Device," Osteoporosis International 2016. DOI: 10.1007/s00198-016-3722-4
SOURCE Bone Index