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CompuMed has received approval from the SFDA of the People's Republic of China to market the OsteoGram system for screening, diagnosing and monitoring osteoporosis.

CompuMed, Inc. (CMPD.OB), provider of diagnostic software solutions, announced it has received approval from the State Food and Drug Administration (SFDA) of the People's Republic of China to market the OsteoGram system for screening, diagnosing and monitoring osteoporosis.

The approval (Reg. # SFDA(I) 20083701577) enables CompuMed to sell the OsteoGram product as an approved clinical device in China and will allow CompuMed to work with its Chinese OEMs to target a market with substantial strategic importance.

"With this approval, we have passed all of the regulatory hurdles necessary to support our effort in the Chinese market where the demographics are very favorable and the incidence of bone disease is very high," said CompuMed CEO Maurizio Vecchione.

Osteoporosis affects more than 200 million people worldwide and is especially prevalent in China, where the traditional diet lacks calcium. According to China's most recent national census, about 100 million Chinese citizens suffer from the disease in various stages.

The OsteoGram is a software-based bone density measurement system that can be used with digital (i.e., filmless) x-ray equipment, as well as with older film-based machines. It provides an accurate, low-cost alternative to DXA bone mineral density (BMD) screening systems, which require dedicated and costly equipment, office space and staff. The OsteoGram's benefits in terms of cost and efficiency can help facilitate more widespread osteoporosis screening and treatment of at-risk patients.