A Medical Device Daily

Thermo Fisher Scientific (Waltham, Massachusetts) said the China Doping Control Center (CDCC) has selected the company as one of its major suppliers of instrumentation and software for the testing of athletes at the 29th Summer Olympic Games in Beijing next year.

The CDCC has been accredited by the Chinese government and the International Olympic Committee (IOC) to conduct all doping control analyses during the 2008 Olympics.

The company said it will provide the CDCC with a range of "high-precision and high-performance Thermo Scientific brand mass spectrometry (MS) instruments," including DFS Sector Field GC/MS systems, the Delta V isotope ratio mass spectrometer and triple-quadrupole TSQ Quantum Access LC/MS systems.

"These instruments and associated software will enable the CDCC to respond to the high volume of samples expected at the Summer Olympics," Thermo Fisher said, adding that it also has agreed to provide technical and application assistance to the CDCC to ensure "uninterrupted operation and secure handing of athlete samples throughout the event."

Marijn Dekkers, president/CEO of Thermo Fisher, said, "Identifying illegal performance-enhancing substances that are used in sports competition is a growing global challenge — one made even more difficult by the development of sophisticated drugs that are increasingly difficult to detect. Our analytical instrumentation is ideally suited to meet this challenge, providing the high specificity and sensitivity, high throughput and reliability required in today's sports environment."

The CDCC testing program will start before the opening of the competition, and continue from the athlete check-in at the Olympic Village until the end of the games. All samples will be analyzed in accordance with the IOC anti-doping rules for banned substances.

Thermo Fisher Scientific is a provider of products and services for scientific purposes worldwide. It has an annual revenue rate of more than $9 billion, employs 30,000 and serves more than 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings.

Its two primary brand names are Thermo Scientific and Fisher Scientific, covering a broad range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents.

Menaflex is new brand name for ReGen

ReGen Biologics (Hackensack, New Jersey) reported the international release of a new brand name - Menaflex - for its collagen meniscus implant device and establishment of a product web site, www.menaflex.com.

"The CMI name was used during the research and development phase of the company's collagen meniscus implant device, and it will continue to be seen in numerous scientific publications and clinical references. Now that we are marketing the product outside the U.S., we will utilize a unique brand name that allows for improved recognition among patients and surgeons," said CEO and Chairman Gerald Bisbee Jr., PhD.

The company said it was launching the associated web site "to advance international awareness and understanding of the Menaflex product and the associated surgical procedure." It said the site "provides a wealth of information regarding knee and meniscus injuries and treatment options, including the Menaflex procedure.

The web site incorporates local country directories of surgeons trained in the Menaflex procedure, from which potential patients can seek additional information and a specific diagnosis.

ReGen said the full transition to the Menaflex name will take about three quarters as it works through current levels of inventory on product and collateral materials.

Crticare, Medrad get Japanese okay

Criticare Systems (Milwaukee) said the last required approval by the Japanese Pharmaceutical and Medical Device Agency (PMDA) was received late last month for the marketing of the Veris MR Vital Signs Monitoring system in that country.

The Veris monitor is manufactured by Criticare and will be marketed through an agreement with Medrad (Warrendale, Pennsylvania)..

The PMDA granted Japanese Good Manufacturing Practice approval, clearing the final hurdle for entrance into the Japanese market. Medrad and Criticare previously obtained approval from Shonin, which reviews a product's operation, safety and labeling.

The companies said bringing the Veris MR Monitor to the Japanese market is "an important milestone" for both Criticare and Medrad, and offers "an exciting opportunity" for continued growth of the MR patient monitoring business.

Another BSD-2000 installation in China

BSD Medical (Salt Lake City) said that another BSD-2000 cancer treatment system is being installed in China, at Central Hospital in Nanchong City in Sichuan Province.

The U.S. firm said it and its Chinese distributor, Dalian Orientech, "have been successful in targeting prestigious hospitals for the BSD-2000 installations."

BSD Medical recently presented at Asia's largest medical device show, the China International Medical Equipment Fair, supporting Dalian Orientech. The exposition showcased the BSD-2000 to more than 42,000 attendees.

The BSD-2000 delivers focused radio frequency (RF) energy into cancerous tumors, including those located deep in the body, raising the tumor temperature to levels required to administer hyperthermia therapy to destroy cancer cells with heat and increase the effectiveness of radiation therapy.

BSD calls itself "the leading developer of systems used to deliver hyperthermia therapy for the treatment of cancer."

Reactor maintenance issue continues

MDS Nordion (Ottawa, Ontario), a provider of medical isotopes and radiopharmaceuticals, has provided an update to its medical isotope customers about a supply issue at Atomic Energy of Canada Ltd. (AECL) that is now expected to extend into January.

The company said it has been informed by AECL that an additional extension of the maintenance shutdown at the National Research Universal reactor will be required in order to complete its upgrade of the electrical back-up system, being done to address a regulatory issue.

MDS Nordion said it is "working closely" with its back-up supply network to mitigate the impact of the AECL shutdown.