Medwave Inc. announced today that it has received 510(k) approval from the US Food and Drug Administration for its handheld blood pressure monitor, the Vasotrax. With this approval, Vasotrax is now available for sale in the United States.
Vasotrax is a wireless handheld device that measures systolic and
diastolic blood pressures as well as pulse rate from the radial artery on the wrist. The 3.5 oz. Vasotrax handheld monitor displays the readings in
approximately 15 seconds. In clinical studies Vasotrax has been shown to have a mean correlation of approximately 0.9 compared to an indwelling arterial catheter. This is significantly more accurate than the traditional blood pressure "cuff." Designed for medical professionals, Vasotrax will contribute to improved patient care and comfort anywhere blood pressures are taken: hospitals, clinics, doctor and dentist offices, ambulatory care, emergency care, home care, EMS environments, etc.
With the necessary regulatory approvals completed, Medwave will begin to expand its current distribution agreements with existing sales companies to encourage rapid market introduction. In addition, Medwave will search for additional distribution agreements in an effort to enter markets where Medwave is not currently present.
"The Vasotrax and its associated accessory products will provide a
significant improvement to the clinician taking their patients blood pressure.
Accuracy of readings are improved, patient comfort, and the time to take a
reading is approximately 15 seconds. We have designed this product with
expansion in mind, in the future we will add the ability to store multiple
patients readings, and download their data into a PC Based system for further
analysis and charting. We believe this is a product, which has a fit into
almost any environment where a professional takes patients' blood pressure and
pulse," stated Mr. Tim O'Malley, President and CEO of Medwave.