A Diagnostics & Imaging Week

Several medical-product companies have reported recent developments involving approval or expanded use of their products in China.

CompuMed (Los Angeles), a developer of computer-aided diagnostic (CAD) solutions, was a featured sponsor of the 1st Peripheral Densitometry Workshop held in Hangzhou, China, last month. Organizers said the workshop served as the launch of a worldwide series of training courses for end users of peripheral densitometers.

The company’s OsteoGram is a software-based system for screening, diagnosing and monitoring osteoporosis. It can be utilized in conjunction with digital X-ray equipment, as well as existing film-based machines.

Dr. Jianhua Wang, a noted orthopedic surgeon from the Aviation Industry Center Hospital (Beijing), highlighted his clinical experience with the OsteoGram in more than 6,000 patients. Wang has been cited by the Beijing city government for his continuing work with the OsteoGram in screening at-risk patients for osteoporosis.

Osteoporosis is a so-called “silent” disease that affects more than 200 million people worldwide and is especially prevalent in China, where more than 125 million postmenopausal women are judged to be at risk. Because the traditional Chinese diet lacks calcium, more than 100 million are estimated to have the disease in various stages.

Lifeline Biotechnologies (Reno, Nevada) said it has completed the testing of its MastaScope device at three hospitals in China. The company said the micro-endoscope provides sharp, clear and accurate imagery of intraductal breast tissues and abnormalities.

The MastaScope was tested on 17 patients by Chinese surgeons under the direction of Dr. Pedro Escobar, MD, of the Cleveland Clinic Foundation. “The MastaScope was very well received by chief breast surgeons at the Zheijang Province People’s Hospital, as well as the China-Japan Friendship Hospital and Beijing Third University Hospital,” said Escobar. “All the scopes and duct excisions were successful.”

Lifeline Biotechnologies has received State Food & Drug Administration regulatory approval for the device in China.

Medical Services International (MSI; Edmonton, Alberta) said it has entered into a joint distribution venture with a Chinese firm and a hospital located in northern China to act as joint distributors of the VScan products in that region.

The hospital will conduct any testing required in order to get any approvals required with regulatory agencies. MSI said that by having the hospital conduct any testing required, access to an established patient base as well as modern laboratories to conduct the testing, the time that it normally takes to arrange testing will be reduced. The hospital also will use the VScan products exclusively whenever possible.

Medical Services International said that all of its previous contracts in China have been with provinces and hospitals in southern China. It said it is reasonable to expect that the new joint venture will result in “significant contracts” in northern China comparable with those it has gathered in southern China, which are expected to generate in excess of $25 million over three years.

The VScan rapid test kits are single-use, disposable tests for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, dengue fever, West Nile virus, syphilis, malaria and prostate cancer.

Distributor set for detection equipment

Universal Detection Technology (UDTT; Los Angeles), a developer of early-warning monitoring technologies to protect people from bioterrorism and other infectious health threats, has signed an exclusive distribution agreement with Security Solutions International (SSI; Miami), a security services company, to distribute UDTT’s anthrax and other bacterial spore monitoring system, BSM-2000, in Central and South America.

Under the agreement, SSI, which specializes in providing emergency preparedness support, will promote the marketing and distribution of the BSM-2000 system in Brazil, Venezuela and the Dominican Republic.

Henry Morgenstern, SSI’s president, said, “We believe that our relationships in Central and South America will provide us the opportunity to introduce the BSM-2000 anthrax detector to a market outside the U.S. The war on terror is a global problem and all countries realize that they are potential targets. The UDTT technology will help provide countries with safety in the face of this threat.”