A Medical Device Daily

Mediscience Technology (Cherry Hill, New Jersey) and Alfanix Technology (ATL) said they entered into an alliance to construct photonics devices for cancer diagnostics, such as the Cancer Diagnostic Ratiometer (CD-R), and to introduce the devices into Latin America for testing on human subjects.

CD-Rs use light fluorescence to distinguish between cancerous and non-cancerous tissues to obtain a more accurate in situ optical Pap test. CD-R results are immediate, whereas diagnosis via conventional Pap smears takes approximately one week. While CD-Rs are seen as a supplement for conventional Pap smears initially, they may eventually serve as a substitute. The alliance was announced jointly by Peter Katevatis, chairman and CEO of Mediscience, and Dr. Robert Alfano, president and CEO of ATL. The alliance will be funded by Mediscience.

As part of the alliance, ATL will oversee the construction for Mediscience of CD-R Beta units for use in clinical testing.

At least two will be used for clinical tests in the Dominican Republic under the supervision of ATL; and at least two will be used for similar trials in the U.S. under the supervision of Mediscience. The objective is to obtain algorithms in order to evaluate and improve the efficacy of CD-Rs on human subjects.

“With a high index rate of [gynecological] cancer among Latin America's female population, there is an urgent need for a more accurate approach to detect and diagnose the disease,“ the company said.

Natus Medical (San Carlos, California) reported that Welch Allyn (Skaneateles Falls, New York), a maker of medical products, has partnered with Natus to bring to market a hearing loss detection solution designed to improve clinical efficiencies by allowing pediatricians to objectively screen for hearing loss in infants, toddlers, and preschool- and school-age children.

“By partnering with Natus Medical we can offer a state-of-the-art solution that will help pediatricians more efficiently care for their patients by more effectively detecting hearing loss, preventing language disabilities, and improving overall patient outcomes,“ said Steve Meyer, executive vice president, Ambulatory Care and Americas at Welch Allyn. “Pediatricians are under constant pressure to save time, screen and diagnose accurately, and treat patients quickly without compromising care.“

“With approximately 30,000 pediatric practices in the U.S., there is a large potential market for this device, and we are very pleased to begin pursuing this growth opportunity with a company with the market reach of Welch Allyn,“ said Jim Hawkins, president and CEO of Natus Medical. “This partnership provides us with a great opportunity to offer pediatricians an objective, easy-to-use hearing screening solution that is backed by the strength of the Welch Allyn brand and the power of its distribution network.“

In other agreements:

The Premier (Charlotte, North Carolina) alliance of nearly 1,500 hospitals and health systems reported a special group buy for Siemens Medical Solutions ' (Malvern, Pennsylvania) imaging systems, as well as associated contrast media injectors from Mallinckrodt (St. Louis) and Medrad (Indianola, Pennsylvania).

The event, which runs through June 30, is expected to offer “considerable savings opportunities to members,“ the companies said.

• Proteome Systems (Boston) reported the signing of an agreement with Egenix (New York) to co-develop a semen-based diagnostic kit for prostate cancer based on the known proprietary Human Carcinoma Antigen (HCA).

The new non-invasive test, once developed, would offer significant advantages over the current test, and would reduce unnecessary invasive examinations as well as needle biopsies.

The current blood test for prostate cancer measures levels of prostate-specific antigen (PSA). The drawback with the PSA test is that it has a high false positive rate (estimated at up to 75%), meaning it picks up many benign conditions of raised PSA levels in the blood – such as enlargement of the prostate or a prostate infection.

This means that many men who have false positive tests for prostate cancer undergo unnecessary biopsies.

Siemens Medical Solutions reported a licensing agreement with the Cleveland Clinic (Cleveland) to market reconstruction and calibration software developed by clinic researchers.

Designed to provide clearer images at a higher resolution than traditional single or multi-pinhole collimators, this advanced SPECT solution could allow researchers to “more quickly and accurately image new diagnostic and therapeutic compounds in preclinical studies,“ the company said. In addition to marketing the software, Siemens expects to release a new multi-pinhole solution based on the clinic's technology.

• Teleflex Medical (Bannockburn, Illinois) reported that Premier Purchasing Partners (Charlotte, North Carolina), the group purchasing organization of Premier (San Diego), awarded a dual-source agreement to Teleflex Medical for its complete line of Pleur-evac chest drainage systems and thoracic catheters.

The three-year agreement began on March 1. Specific products included in the award are the Pleur-evac Sahara S-1100 dry series, Pleurevac wet series and Pleurevac high suction control series of products.

• Telzuit Medical Technologies (Orlando, Florida) reported that it has signed a co-marketing agreement with external counterpulsation (ECP) equipment maker Cardiomedics (Irvine, California) for the sale of Telzuit's BioPatch Wireless Holter Monitor System through Cardiomedics' existing sales and marketing channels.

Comprised of 26 internal and contracted sales staff, the Cardiomedics sales force intends to market the BioPatch alongside the company's ECP equipment, including the CardiAssist and CardiAssess Systems.

With a client base of more than 500 cardiologists, Cardiomedics said it expects to place several thousand BioPatch units into the market within the first 12 months of usage. Terms of the agreement were not disclosed.

HealthTronics opens anatomical pathology lab

HealthTronics (Austin, Texas) said it has opened its anatomical pathology laboratory focusing on service to the urology community, in a life sciences building on the campus of the Medical College of Georgia (Augusta, Georgia).

John Barnidge, interim president and CEO, said, “Our customers and physician partners will benefit from technological innovations, including web-based reporting capabilities and bar code assisted workflow. With input from our physician partners, we have also developed a unique, patent-pending biopsy kit to maximize efficiencies and quality assurance for both the physician and lab personnel.“

HealthTronics provides services related to urology in addition to making medical devices. It also manufactures specialty vehicles used for the transport of high-tech medical devices and broadcast and communications equipment.

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