A Medical Device Daily Staff Report

U-Systems (Sunnyvale, California), a developer of automated breast ultrasound, reported that it has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the somo•v Automated Breast Ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in Canada.

The somo•v ABUS ultrasound device is intended for use as an adjunct to mammography to provide physicians with an increase in the sensitivity of breast cancer detection in diagnostic symptomatic and screening asymptomatic women.

The company says that the system is the only ultrasound device approved for breast cancer screening by Health Canada, the agency responsible for assessing medical device safety, effectiveness and quality in Canada. It is also the only ultrasound device approved for breast cancer screening in the 27 European Union countries. In the U.S., the system is cleared by the FDA for adjunctive diagnostic use with mammography.

“With this approval from Health Canada, we are proud to make this critical screening tool available to improve the early detection of breast cancer in Canada,“ said Ron Ho, president/CEO of U-Systems. “The somo•v Automated Breast Ultrasound System is not intended as a replacement for mammography. However, there is a growing body of scientific evidence that supplementing mammography with ultrasound detects more cancers than mammography alone.“

Using proprietary technology to automate the breast ultrasound imaging process, the company says that the system is ideally suited for the high-volume, screening environment. The somo•viewer Advanced 3D Workstation enables fast review and archive of patient exams, optimizing breast ultrasound screening workflow.

U-Systems is also the sponsor of the national SOMO•INSIGHT Clinical Study, which is designed to evaluate whether digital mammography in combination with somo•v ABUS is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue. More than 15,000 women have participated in the study which is actively recruiting up to 20,000 women at multiple breast imaging centers nationwide. To date, the study has identified a significant number of mammographically negative breast cancers that were subsequently detected by ABUS.

Dehaier reports Chinese product approvals

Dehaier Medical Systems (Beijing), a company developing devices and homecare medical products in China, reported it was granted export certificates for five homecare medical products by the State Food and Drug Administration (SFDA) of the Peoples Republic of China (PRC).

The certificates, which were issued in June 2011 and are valid for two years, allow for Dehaier's Sleep Diagnostics product DHR-998, Dehaier Continuous Positive Airway Pressure (CPAP) products - DHR-AUTO-A8, C5, and C6, and the Dehaier Medical Air Compressor - to be exported without restriction, and serve as validation that the products meet PRC government requirements for sale and shipment overseas. Those certificates are necessary because it is prerequisite for certain countries.

The company also reported that it was awarded a new design patent for its sleep diagnostics products by the State Intellectual Property Office (SIPO) of the PRC. The new design patent, issued in July 2011 and valid for 10 years, increases the Dehaier intellectual property portfolio to six patents and five software copyrights, as well as proprietary technology.

“We are making progress toward expanding our business beyond China's borders, and believe the award of these export certificates is a critical first step to extending our geographic footprint,“ said Ping Chen, CEO of Dehaier. “Moreover, we are committed to investing in ongoing innovation, as we look to expand our addressable market through current product enhancements and new product introductions. We believe such a strategy will enable Dehaier to achieve its goal of meeting our customers' individual needs with a growing selection of homecare products.“

Dehaier develops and assembles its own branded medical devices and homecare medical products from third-party components. The company also distributes products designed and manufactured by other companies.