CompuMed Receives Regulatory Clearance By China's State Food And Drug Administration For OsteoGram Product For Monitoring Osteoporosis

CompuMed, Inc. (OTCBB:CMPD) -- a medical informatics company serving the healthcare community with 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.


About CompuMed


CompuMed, Inc. (OTCBB:CMPD) develops and markets products and services that combine advanced imaging with medical informatics. Its focus is on analysis and remote monitoring for patients with cardiovascular and musculoskeletal diseases. The Company has specialized expertise and intellectual property in telemonitoring imaging and analysis designed to improve healthcare provider workflow and patient care while reducing costs. CompuMed's core products, the OsteoGram(R) and CardioGram(TM), are cleared by the FDA and reimbursable by Medicare. The OsteoGram is a non-invasive diagnostic system that has been proven by many clinical studies to provide effective and accurate bone density measurement for screening osteoporosis and assessing hip fracture risk. The OsteoGram has significant cost advantages over other technologies in the marketplace. The CardioGram system is one of the first telecommunication networks designed to remotely interpret electrocardiograms and is used by private practice, as well as government and corporate healthcare providers nationwide. The CardioGram delivers online electrocardiogram interpretations within minutes of receipt and has the additional capability of automatically providing an over-read (i.e., follow-up review) by a cardiologist. CompuMed is headquartered in Los Angeles and distributes its products worldwide both directly and through OEM partners. Visit CompuMed on-line at compumed.


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