A Medical Device Daily

Beckman Coulter (BC; Fullerton, California) has been awarded a grant by the Imperial College London to develop a point-of-care (POC) test for monitoring CD4 lymphocytes in patients with HIV/AIDS, needed in resource-poor countries like sub-Saharan Africa to assess prognosis and aid in treatment decisions for HIV/AIDS patients.

The grant is the second awarded to BC by Imperial College London’s CD4 Initiative funded by the Bill & Melinda Gates Foundation (Seattle). The first grant, awarded in March, provided funding for the development of quality assurance and quality control (QA/QC) materials used to verify the accuracy and validate the new test. Sybil D’Costa, PhD, staff advanced research scientist for BC’s Custom Biopharma Solutions, is the principal investigator on both projects.

BC will begin working with Imperial College London to develop the new test designed for use in extreme environments and remote settings where electricity, clean water and trained healthcare technicians may or may not be available. The goal is that the new test will involve a finger prick blood sampling methodology and will require minimal technical expertise to decipher.

Prior to commercialization, the POC assay will be tested cby comparing its performance to BC’s gold standard, tetraONE CD4 cell enumeration system. Tests will be compared using blood from the same donor, and both normal and HIV positive samples will be evaluated to ensure the highest level of accuracy.

Recent reports indicate there are nearly 40 million people living with HIV worldwide with 64% of them living in the extremely resource limited settings of sub-Saharan Africa.

In contract news:

• Merge Healthcare (Milwaukee), a medical imaging software and services provider, reported several new contracts for Fusion RIS/PACS MX, a solution for clinical and business imaging workflow, released in April.

They include: Atlanta Radiology Consultants (Atlanta); Center for Medical Imaging (Germantown, Wisconsin); Zwanger-Pesiri Radiology (Long Island, New York).

Merge says its research identifies market needs for PACS and RIS technologies — especially in freestanding imaging centers and in hospitals with fewer than 200 beds. The hospitals represent nearly 70% of all U.S. acute care hospitals, while in the U.S. freestanding imaging centers have grown in number from 4,000 to 6,000 in the last five years.

• Amplifon USA (Plymouth, Minnesota), a distributor of hearing aids, has appointed Vanco (Chicago), a global virtual network operator (VNO), to design, implement and manage a data network solution for its corporate-owned clinics.

The four-year agreement, worth more than $1.2 million, will deliver end-to-end connectivity to 243 locations across the U.S. and Canada, Amplifon noted. The Vanco service will use broadband technology to deliver a high bandwidth network solution to accommodate Amplifon’s store applications, the company said. The solution will expand upon an existing relationship with the Amplifon Group , the parent company.

Amplifon USA, a subsidiary of Amplifon S.p.A. (Milan, Italy), distributes hearing aid products through Miracle-Ear, Sonus and Amplifon Hearing Aid Centers.

In 2005, Vanco bought Universal Access (Chicago), a provider of carrier-neutral wholesale layer 1 network solutions, to form the heart of its VNO Division. The VNO Division enables telecom carriers, integrators, outsourcers and cable operators like Bell Canada, Asia Netcom, ARINC and Adelphia to expand their networks to reach customers outside of their embedded footprint.

Product Briefs

• Endovalve (San Francisco) reported that it has developed a to-scale functional model of the valve and anchor design, successfully demonstrated important feasibility criteria and begun preclinical animal testing. “The functional 1x-scale model of the valve and anchor design, which is the linchpin of our mitral-valve replacement system, has successfully demonstrated such feasibility criteria as foldability and deployment of the nitinol and stainless steel device,” Endovalve president/CEO Robert Wilkins told attendees at the Medtech Insight Investment In Innovation Medical Device Summit. Endovalve makes percutaneous valve-replacement systems to treat mitral regurgitation.

• Imaging3 (Burbank, California), reported that it plans to file an FDA 510(k) submission with by June 15th for the Dominion 3D real-time imaging device. The submission is a device equivalent submission comparing the functionality, intended use and energy transmission with similar devices currently on the market. “We hope to obtain FDA approval by year-end, but understand the process could continue into 2008. We have generated enough data through our initial stages of Beta Testing that we are now confident we can proceed with the FDA filing,” stated Dean Janes, CEO and chairman. Imaging3 makes medical imaging devices.

• Verathon (Bothell, Washington) reported the introduction of the GlideScope cobalt, a single-use video laryngoscope that provides a real-time view of the patient’s airway, enabling quick intubation. Developed for operating room, emergency department, and intensive care unit applications, the GlideScope Cobalt single-use design, which eliminates the need for disinfecting the “blade,” is ideal for fast-paced intubation settings. The video laryngoscopes provide a real-time view of the airway and of endotracheal tube placement, minimizing the need for a “blind” intubation procedure. GlideScope cobalt consists of a slim video baton which houses a high-resolution camera with a patented anti-fogging mechanism to resist lens contamination; a non-glare color monitor; and single-use, sterile GVL stats in large and small sizes that offer a patented 60-degree blade angulation. Verathon makes medical devices and services that offer improvement in patient care to the health care community.

• Zygote Media Group (Concord, Massachusetts) said its using3D CAD software from SolidWorks (Concord, Massachusetts) to ensure the term “anatomically correct” applies to the products its customers develop. A SolidWorks solution partner, Zygote says it is building hyper-accurate 3D models of the human body, including skeleton, heart, arteries, nerves and muscle tissue for customers to develop better products in the biomedical, entertainment, athletic gear, and video gaming industries. It says that biomedical companies, for example, use heart models to develop stents to place in damaged arteries and skeletal models to design a brace that may straighten a crooked spine. Increasing demand from medical device manufacturers for anatomy models generated in SolidWorks prompted Zygote to adopt the 3D CAD software. Zygote Media Group is a provider of 3D human anatomy content. SolidWorks Corporation makes software for design, analysis, and product data management.

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