FDAnews Device Daily Bulletin

MEDWAVE FILES 510(K) APPLICATION FOR PRIMO

Nov. 28, 2005
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Device firm Medwave has filed an application with the FDA for its Primo noninvasive blood pressure monitoring system.

The company, in conjunction with researchers and clinicians at Massachusetts General Hospital in Boston, has completed the necessary clinical validation studies with the Primo product, Medwave said.

The performance of Primo was tested against that of an invasive arterial catheter. The clinical validation studies were conducted according to the American Association for Advancement in Medical Technology SP10 standard that provides labeling, safety and performance criteria for non-invasive blood pressure equipment, Medwave said.

The Primo will be able to address a host of market needs in a variety of market segments, said Tim O'Malley, president and CEO of Medwave. The product delivers accurate readings that are comparable to an invasive catheter, he added.

"Primo is nonocclusive, so it comfortably obtains a blood pressure reading in approximately 15 seconds," O'Malley said. "We believe that Primo will have broad appeal in numerous healthcare environments and will have the capability of addressing markets representing approximately $600 million in annual revenue."