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BIOSYSS SUBMITS 510(K) FOR BIOWAVE BPM 1 NON-INVASIVE BLOOD PRESSURE

This article was originally published in The Gray Sheet

Executive Summary

BIOSYSS SUBMITS 510(K) FOR BIOWAVE BPM 1 NON-INVASIVE BLOOD PRESSURE monitoring system on Sept. 28, the firm announced Sept. 29. The device, according to the company, is the first non-invasive system to provide blood pressure readings on a continuous basis. The BioWave BPM 1 constantly records pulse waveform through piezoelectric sensors that are placed on the patient's wrist. The pattern of the pulse waveform is then analyzed "using complex signal-processing techniques and proprietary algorithms" and translated into blood pressure readings. The device's monitor displays a visual of the waveform as well as numeric readings of systolic, diastolic and mean blood pressure and pulse rate. The device was tested in three clinical trials "on more than 150 patients" at Brigham & Women's Hospital in Boston, Sarasota Memorial Hospital in Florida and New Hampshire Heart Institute in Manchester. BioWave BPM is Biosyss Corp.'s first product. Founded in 1989, the privately held company has raised $1.4 mil. in financing to date, primarily from physicians. The Braintree, Massachusetts firm also has a letter of agreement with the investment banking firm Adams, Harkness & Hill for another $4 mil. in private financing. The seven-person company is headed by Jeffrey Barnes, formerly a technical marketing manager for Hewlett-Packard.
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