CardioDynamics preparing 510(k) for BioZ noninvasive hemodynamic monitor.
This article was originally published in The Gray Sheet
CARDIODYNAMICS BIOZ NONINVASIVE HEMODYNAMIC MONITOR 510(K) SUBMISSION is slated for the end of July, the company says. CardioDynamics expects to commence clinical trials over the next three months at 10-15 sites with 50-100 patients per site. Study sites include Brigham and Women's Hospital, Boston; Scripps Clinic and Research Foundation, La Jolla, California; University of California at San Diego; Arizona Heart Institute, Phoenix; University of Washington, Seattle and the Mayo Clinic, Rochester, Minnesota.
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