A Medical Device Daily

China has returned five pacemakers imported from the U.S. in April after quality tests found problems the country’s quality regulator said could be “major” health hazards.

A Bloomberg News report, which included reporting by the Star Tribune of Minneapolis, said labels on the pacemakers, made by St. Jude Medical (St. Paul, Minnesota), did not accurately reflect the devices’ voltage settings. That information was attributed to a statement posted on the General Administration of Quality Supervision, Inspection and Quarantine web site.

The agency examined, in all, 272 St. Jude pacemakers. The products were tested by quality inspectors in Shanghai in April and five were returned “recently,” according to the statement.

St. Jude acknowledged mislabeling on five devices but said that the mislabeling did not affect product performance or patient safety.

“St. Jude respects China’s efforts to ensure standards of quality for medical devices. We are equally committed to these high standards for all of our products around the world,” spokeswoman Kathleen Janasz told the news service.

The Bloomberg report noted that recent reports of unsafe Chinese products ranging from contaminated fish to pesticide-laced vegetables have intensified trade friction between the U.S. and China.

While defending the quality of its exports, China also pledged to strengthen quality control of foreign products coming into the county. Those that fail to meet Chinese standards will be “destroyed, returned or banned from being imported,” the quality regulator said in Monday’s statement.

“There’s likely to be an element of retaliation there,” said Du Jinsong, a Hong Kong-based analyst with Credit Suisse Group. Tighter quality controls on imported medical devices suggest that Chinese companies will “find it easier to take market share from foreign players,” Du said.

The Xinhua News Agency reported last week that China’s Food and Drug Administration launched an investigation in 2001 into four types of pacemakers produced by St. Jude Medical because of reliability issues, resulting in imports of the pacemakers being banned. It didn’t say whether the banned pacemakers were the same type as those returned to St. Jude recently.

U.S. firm, University of Alberta in accord

Microchip Biotechnologies (MBI; Dublin, California) and TEC Edmonton have entered into an exclusive patent license agreement that allows MBI to commercialize an invention out of the University of Alberta (Edmonton) designed to improve the development of lab-on-a-chip devices and biosampling procedures.

“The licensing of this fundamental patent on manipulating beads-on-chip continues to build upon our strong intellectual property position in microfluidic devices,” said Stevan Jovanovich, president/CEO of MBI. “Microfluidic devices will play a critical role in next-generation instrumentation in delivering fully automated, cost-effective solutions for life science, applied science and diagnostic products for laboratory and field-based applications.”

MBI will use the technology patented by TEC Edmonton, the technology officially called an “Apparatus and Method for Trapping Bead Based Reagents within Microfluidic Analysis Systems” (U.S. patent No. 6,432,290).

A team led by Dr. Jed Harrison, professor and chair in the university’s Department of Chemistry, invented the technology to allow trapping of beads-on-chip, as well as packing and unpacking the trapping zones, which significantly extends the applications of microfluidic analysis systems, such as those used in biodefense and genomics industries.

Microfluidics deals with the behavior, control and manipulation of microliter and nanoliter volumes of fluids and is used in the development of devices such as DNA chips, micro-propulsion and lab-on-a-chip technology.

TEC Edmonton is the exclusive technology transfer office for the University of Alberta.

MBI is an early-stage, privately-held company developing advanced nanofluidic sample preparation and analytical instrumentation for life sciences, applied sciences and diagnostics markets.

Direx Systems in distribution accord

Direx Systems (Canton, Massachusetts), an exclusive manufacturer for Initia Medical Technologies (Tell Aviv) in the U.S., has signed a distribution agreement with Oncology Services International (OSI; Ramsey, New Jersey).

OSI will market Initia-RT’s (Petah Tikva, Israel) COLOR=#008CAE> products for radiotherapy in the U.S. Initia-RT’s current product offerings include TrackLeaf mMLC with crossleaf architecture and four sets of leaves, and CrossPlan, a comprehensive treatment planning software.

In addition, Initia is preparing for release of its products in the area of image-guided radiation therapy (IGRT), including TrackBeam real-time imager incorporating dynamic tracking and treatment delivery.

OSI is a provider of refurbished radiotherapy equipment and services, while Initia RT’s products complement OSI’s portfolio by allowing it to upgrade its equipment to deliver more complicated treatment techniques, including stereotactic radiosurgery (SRS), intensity-modulated radiation therapy (IMRT) and IGRT.

“We are very pleased to have OSI as a partner in the U.S. Their nationwide sales and service organization will significantly increase our visibility and proximity to the customer,” said Gaby Henkin, CEO of Direx.

Focused on the radiotherapy market, Initia-RT, a division of Initia Medical Technologies, has expertise in imaging, beam modulation and software development.

Xenomics CSO to speak at Moscow meeting

Xenomics (New York), a developer of DNA diagnostic technologies, reported that Samuil Umansky, MD, PhD, the company’s co-founder and chief scientific officer, has been invited to make a presentation regarding the company’s transrenal nucleic acid (Tr-NA) technology at this week’s 5th International Symposium on Circulating Nucleic Acids in Plasma and Serum (CNAPS-5) in Moscow.

Umansky’s presentation will describe the most recent achievements in Tr-DNA/RNA technology and development of specific tests.

Umansky will present data on practical applications of new methods of Tr-NA isolation and use of ‘ultrashort” PCR amplicons for developing pre-natal tests, as well as tests in areas of oncology and infectious diseases. He also will discuss how new techniques for Tr-NA purifications led to the discovery of both ubiquitous and transrenal tissue-specific microRNA (miRNA) in the urine.