10 jan, 2009
CalHealth Receives FDA Approval For its Innovative MDMouse™ Blood Pressure Monitor
IRVINE, Jan 10, 2009 /PRNewswire/ – CalHealth, Inc., an Irvine-based company developing home health monitoring solutions, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) as a 510(k) class II medical device for its MDMouse™ blood pressure monitor, an innovative blood pressure monitor system for use with personal computers.
The MDMouse monitor incorporates a finger cuff mechanism inside a computer mouse. The ergonomic optical mouse connects through the PC’s USB port, and is used like a normal mouse. But inside the mouse is a unique blood pressure monitor consisting of a rotating finger cuff and proprietary algorithms for accurately determining systolic and diastolic blood pressure and pulse rate. The user can also create automatic alerts to remind when it is time to take a blood pressure reading, and historical measurement data is available for review. The data can also be automatically uploaded directly to personal health records for review by the user's physician.
Terry Malloy, Chief Executive Officer of CalHealth, Inc. said of the MDMouse solution, "High blood pressure, or hypertension, is one of the most serious and impactful health conditions globally. Awareness and regular monitoring are key to controlling hypertension, however current monitors are cumbersome and inconvenient and infrequently used. Patients and the health care industry both are seeking a better solution that will enable regular tracking and access to the collected data. The MDMouse monitor provides a convenient and easy to use solution that is conveniently on the user’s desktop, making it simple and fast to regularly monitor blood pressure. Now, with the FDA’s approval, CalHealth can move forward in bringing this innovative solution to the growing market.""