Medical Device Daily
The Laboratoire National d’Essais (LNE; Trappes-Elancourt, France) has expanded its footprint for international certification of medical devices by sharpening its focus on orthopedic devices in the American market and winning recognition as a certification body (CB) for electromedical devices in 49 countries.
LNE set up an office for its division that focuses on medical device certification, called G-MED, in 2005 in Silver Springs, Maryland, close to the sprawling offices of the FDA. With 10% of its international customers in the orthopedic market, G-MED is successfully parlaying this specialized skill among U.S. companies.
Last November LNE/G-MED was chosen by NuVasive (San Diego) for third-party certification of its new line of MaXcess minimally invasive specialized spinal implants that is currently undergoing clinical investigation.
Demonstrating conformity through a single CB testing procedure will assure NuVasive certification for MaXcess in the countries currently participate in the CB program. This international harmonization includes FDA approval through the 2002 Medical Device Modernization Act authorizing the Inspection by Accredited Persons (IAP) program, a CE mark for European markets, as well as approval for global markets that include China, India, Japan, Australia, Korea, Russia, Brazil, Canada and Argentina.
Many countries not formally participating in the CB program nonetheless use the certification planning and audit process as the basis for their national certification procedures.
For orthopedics, G-MED builds on an expertise acquired by LNE since 1980, when French regulations set out stringent mechanical and material characteristics for implanted devices.
Marc-Henri Winter, president of G-MED North America, pointed out that while it is common in the medical device industry, and especially in the orthopedic sector, to subcontract the design and realization of products, “experience shows that in some cases this externalization may be at the origin of issues.” He said LNE/G-MED’s work in the orthopedic industry shows situations where a lack of control of outsourced activities has direct consequences for the legal manufacturer.
At the beginning of this month, G-MED reported that it was recognized by the International Electrical Commission System for Conformity Testing and Certification of Electrical Equipment as a National Certification Body and a Certification Body and Testing Laboratory in the context of the international certification body program covering electromedical devices.
LNE, established in 1901 as part of the Conservatoire National des Arts et M tiers, today employs 700 and operates from a 21-acre complex of laboratories and facilities just outside of Paris. Formerly attached to the French Ministry of Industry, G-MED emerged as France’s key certification body in the medical field and was spun off to become a public company in 2004.
Sectra in PACS provider accord for London
IT and medical technology company Sectra (Stockholm, Sweden) said it has signed a comprehensive agreement with British Telecommunications (BT) to provide picture archiving and communications system (PACS) products and services to the majority of London’s public hospitals.
British Telecom is the Local Service Provider for the NHS London Program for IT. BT has been providing Sectra’s PACS to London trusts of the National Health Service via a former Sectra partner since 2004.
Under the agreement, Sectra will, as a subcontractor to BT, begin to assume direct responsibility for the support and maintenance of the systems and also will supply additional PACS products.
The 21 London trusts operate 25 hospitals that combined perform more than 4 million radiology examinations annually, Sectra said.
“This agreement confirms our ability to provide timely, first-class service and support,” said Torbj rn Kronander, president of Sectra’s medical operations. “To be chosen to take over the service responsibility of such a large group of critical radiology operations is an acknowledgement [of] our very capable staff.”
In addition to direct sales efforts, Sectra continues to offer direct PACS service and support agreements to any customers that previously purchased Sectra products through partners.
Sectra makes IT systems and products for radiology, mammography and orthopedic departments. More than 950 hospitals worldwide use its systems, performing more than 40 million radiology examinations annually.
UK firm submits warfarin test to FDA
Osmetech (London), a developer of molecular diagnostics, said it has submitted its eSensor 2C9/VKOR test to the FDA for 510(k) clearance. The test is to be used as an aid in the identification of patients at risk for increased sensitivity for the widely used blood-thinning drug, warfarin.
Clinical studies were performed at three evaluation sites in the U.S. using the company’s next-generation eSensor XT-8 instrument. These followed pre-clinical studies completed in November where 345 samples were tested using the eSensor 2C9/VKOR method and found to be in 100% agreement with results from bi-directional DNA sequencing, the company said.
CEO James White said, “We are [pleased] with the performance of our warfarin test and are confident of achieving FDA clearance to launch [the] test in the first half of 2008. We believe that the eSensor 2C9/VKOR warfarin test has many key attributes which should lead to commercial success in this growing and significant market.”
Osmetech said that in the U.S. alone, more than 30 million warfarin prescriptions were made last year, including an estimated 2 million new patients. It said warfarin is the second-most-likely drug, after insulin, to send Americans to the emergency room, resulting in an estimated 43,000 ER visits a year in the U.S.
According to the company, a recent economic study concluded that widespread use of warfarin testing in the U.S. could avoid 85,000 serious-bleeding events and 17,000 strokes a year, and save about $1.1 billion annually.
Osmetech has U.S. operations in Boston and Pasadena, California.