The approval enables CompuMed to sell the OsteoGram product as an approved clinical device in China and will allow CompuMed to work with its Chinese original equipment manufacturers to target a market with substantial strategic importance.
CompuMed’s OsteoGram is a software-based bone density measurement system that can be used with digital x-ray equipment, as well as with older film-based machines.
Maurizio Vecchione, CEO of CompuMed, said: “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.”