Medwave files 510(k) review application for Fusion

By Elaine Rigoli

Tampa, Fla., June 13 - Medwave, Inc. has submitted a 510(k) application to the Food and Drug Administration for its Fusion non-invasive patient monitor system with vital signs options.

Medwave, in conjunction with staff members at the University of Minnesota Medical Center, Fairview in Minneapolis, have completed the necessary clinical validation studies with the Fusion product, according to a news release.

These clinical validation studies were conducted according to the applicable standards that provide performance criteria for non-invasive blood pressure equipment and vital signs monitoring products, the release said.

Located in Danvers, Mass., Medwave develops, manufactures and distributes sensor-based non-invasive blood pressure solutions.

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