A Medical Device Daily

Masimo (Irvine, California) said that it has signed a three-year, dual-source agreement with Novation (Irving, Texas), the healthcare contracting services company of VHA (also Irving) and the University Health System Consortium (UHC; Oak Brook, Illinois).

The agreement covers Masimo SET pulse oximetry and Masimo Rainbow SET Pulse CO-Oximetry, including stand-alone monitoring devices, hand-helds and sensors. The competitive bid process involved an extensive clinical review and a technology value analysis by Novation's pulse oximetry task force.

Masimo is the inventor of read-through motion and low-perfusion pulse oximetry, a technology called Masimo SET (for Signal Extraction Technology), which it said has been proven more accurate and reliable in the most challenging clinical settings by more than 100 independent clinical studies.

Building on this technology platform, Masimo has recently introduced Masimo Rainbow SET, a new technology that uses eight wavelengths of light to allow clinicians to capture and monitor an unprecedented array of patient physiological data non-invasively. Rainbow SET capabilities will be available in Masimo monitors and in multi-parameter patient monitors produced by leading manufacturers.

The Rad-57 Pulse CO-Oximeter, the first FDA-cleared Rainbow SET product from Masimo, is a hand-held device that allows clinicians to detect and monitor carbon monoxide levels in the bloodstream non-invasively.

In clinical studies and in the field, Rad-57 has proven itself effective in detecting carbon monoxide poisoning in seconds, allowing accurate diagnosis and early treatment of a life-threatening problem that frequently is misdiagnosed as flu or migraine.

Masimo said that it has other new Rainbow SET monitoring capabilities in advanced development and that the ability to non-invasively detect and monitor methemoglobin levels in the blood is pending FDA clearance. A recent Johns Hopkins University (Baltimore) study found that methemoglobinemia, a potentially lethal condition that starves the tissues of oxygen, is much more common in hospitalized patients than previously realized.

Joe Kiani, Masimo's chairman and CEO, said that since being added to the Novation contract in 2003, the company's annualized sales to Novation hospitals have increased by more than 5000%.

In other news, MSA (Pittsburgh) said it has secured a five-year $36 million indefinite delivery/indefinite quantity contract from the U.S. Air Force to develop and supply a new and versatile respiratory protection system for use by air base firefighting squads.

The initial award, representing $5.6 million over 12 months, covers design, prototype development, testing and attaining product certifications from the National Institute for Occupational Safety and Health (NIOSH) and the National Fire Protection Association (NFPA).

Company officials noted that 2006 revenue from the contract would likely be a small portion of the initial award based on the anticipated timeframe to complete the above development activities.

The multi-function breathing apparatus is one of the "most advanced respiratory protection systems ever developed," the company said. It combines the advanced and high-performance features of MSA's latest-generation self-contained breathing apparatus with those of a powered air-purifying respirator and gas mask to provide firefighters with a three-way, long-duration respiratory protection solution.

Pending NIOSH and NFPA certifications, the system will also provide Air Force personnel with approved protection from chemical, biological, radiological and nuclear contaminants.

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