Optasia's SpineAnalyzer cleared in US
This article was originally published in Clinica
Executive Summary
SpineAnalyzer, software that helps diagnose vertebral fractures in people at risk of osteoporosis, has received 510(k) clearance from the US FDA. Developed by Cheadle, UK-based company Optasia Medical, the workflow tool analyses X-ray images or dual energy X-ray absorptiometry (DXA) scans to identify vertebral deformities, which can be missed by X-rays or DXA alone. Only around 25% of the fractures are clinically apparent using these conventional methods, Optasia estimates. In addition 20% of women who are not considered to have osteoporosis according to the gold-standard measure, bone mineral density, have vertebral fractures. As patients with these fractures are more likely to suffer from future osteoporotic fractures, SpineAnalyzer could identify more people who would benefit from preventative treatment. Optasia launched the product outside the US in September 2009 (see Medtech Ventures, February 2010).