A Medical Device Daily
CompuMed (Los Angeles), a provider of diagnostic software solutions, said it has received approval from China's State Food and Drug Administration (SFDA) to market its OsteoGram system for screening, diagnosing and monitoring osteoporosis.
The approval enables CompuMed to sell the OsteoGram product as an approved clinical device in China and will allow the company to work with its Chinese OEMs to target a market with "substantial strategic importance."
CEO Maurizio Vecchione 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."
CompuMed noted that osteoporosis affects more than 200 million people worldwide and is "especially prevalent" in China, where the traditional diet lacks calcium. It said that, according to China's most recent national census, about 100 million Chinese suffer from the disease in various stages.
The 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. CompuMed said it provides an "accurate, low-cost alternative to DXA bone mineral density screening systems, which require dedicated and costly equipment, office space and staff."
The company said OsteoGram's benefits in terms of cost and efficiency "can help facilitate more widespread osteoporosis screening and treatment of at-risk patients."
New distributors for WaferGen
WaferGen Biosystems (Fremont, California), a developer of gene expression, genotyping, cell biology and stem cell research systems, reported the signing of exclusive distribution agreements for the company's SmartSlide Micro-Incubation System with Bucher Biotec in Switzerland, Unimed Healthcare in Taiwan and AH diagnostics in the Nordic region of Denmark, Sweden, Norway and Finland.
The distributor agreements cover WaferGen's entire family of SmartSlide Micro-Incubation System products. Each of the new distributors are active in selling to cell biologists and stem cell researchers in the life science markets within their geographic areas of focus.
The SmartSlide Micro-Incubation System is a first-of-its-kind family of integrated fluidics exchange micro-incubation products that work seamlessly with inverted microscopes. The company said this technology is enabling researchers to conduct complex time-lapse imaging studies to characterize, differentiate and proliferate cells, as well as grow stem, primary and other difficult to cultivate cells in consistently optimal physiological conditions.
These capabilities will allow researchers to pursue research topics that are not addressable with existing technology, WaferGen said.
"These key distributor agreements represent ... another important milestone in our strategic efforts to expand the reach of our SmartSlide Micro-Incubation System into new key foreign markets," said Chairman/CEO Alnoor Shivji. "We expect to continue to build our SmartSlide Micro-Incubation System customer base with additional international distributor agreements this year."
DaVita mission opens in India
Bridge of Life–DaVita Medical Missions, a non-profit organization founded by DaVita (both El Segundo, California) that focuses on bringing kidney dialysis services to developing countries, has opened the doors to its newest dialysis clinic in India.
The new clinic is located in the Mishirmal Bafnal Parmarath Hospital (Jodhpur) and is the first of two clinics that Bridge of Life-DaVita Medical Mission's partner, International Health Benefit Services, plans to open in India this summer with the support of the non-profit organization.
The dialysis clinic will treat kidney patients at a minimal cost, bringing relief to the region's government hospitals.
In partnership with several healthcare providers and local physicians, Bridge of Life-DaVita Medical Missions also held a "Renal Awareness Camp" in Jodhpur, India, in late April, providing free healthcare screenings, early detection and education materials on kidney disease and kidney failure to more than 150 residents.
Bridge of Life-DaVita Medical Mission translated many of the kidney care resources available in the U.S. and customized them for the Indian diet, lifestyle and culture. That provides a comprehensive toolkit to ensure that the people of Jodhpur are better educated on end-stage renal disease and chronic kidney disease.
DaVita specializes in kidney care, providing dialysis services and education for patients with chronic kidney failure and end-stage renal disease.
AmeriCares delivers more aid to China
AmeriCares (Kirkland, Washington), a nonprofit international relief organization, has delivered a second deployable field hospital to China's earthquake-devastated Sichuan Province, where health concerns remain acute following last month's deadly 7.8-magnitude quake.
This second field hospital was deployed in Wenchuan County, which was the epicenter of the earthquake. The new hospital is set up on the site of the former Xuankou Township Hospital, which received severe structural damage.
Medical personnel have been working out of a collection of tents on the site, seeing up to 200 patients a day. The new hospital includes operating and emergency rooms, a laboratory, radiology unit and a patient ward.
CRO closes on 'A' round
Contract research organization Tigermed Consulting (Shanghai, China) said it has closed its Series A financing from Qiming Venture Partners (also Shanghai).
With the capital injection, Tigermed said it has entered into a period of rapid expansion. It already is one of the largest CROs in China.
"Over the past six years, we have established a globally competitive team with more than 100 professionals. We have set up 13 offices in both the U.S. and China, with 150 business customers from both home and abroad," said Dr. Ye Xiaoping, CEO/founder. "Our leading management and service system and our data management system have laid a solid foundation for the rapid development of [the company]."