March 15, 2004 FDA 510K Clearance - Remote Monitoring of Blood Pressure and Blood Glucose
HEALTH HERO NETWORK RECEIVES FDA CLEARANCE TO MARKET BLOOD PRESSURE MONITOR AND ADDITIONAL BLOOD GLUCOSE METERS
510(k) Clearance Expands Available Health Buddy® System Medical Device Options
Mountain View, CA - March 15, 2004 – Health Hero Network announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the list of medical devices for use with its Health Buddy® system. A blood pressure monitor and three blood glucose meters are included in the current clearance, giving patients and health care providers the ability to select the most appropriate medical device(s) for their patient management needs. The Health Buddy system offers healthcare providers an effective way to monitor patients’ chronic conditions, including the collection of historical clinical information, health self-assessment, symptoms, and vital signs while facilitating ongoing patient education.
The 510(k) clearance adds the A&D UA-767 digital blood pressure monitor to the list of medical devices that can connect to the Health Buddy appliance. The TheraSense Freestyle® and Freestyle Flash™ and the LifeScan One Touch® Ultra® blood glucose meters were added to those cleared in 1999, bringing the total number of compatible blood glucose meters to eight.
“The new clearance adds more freedom of choice and flexibility for both providers and chronically ill patients to select the medical device that’s right for them when using our system,” said Steve Brown, Health Hero Network CEO and President. “In the coming months, Health Hero Network will add additional blood pressure cuffs and state of the art devices such as peak flow meters compatible with the Health Buddy system.”
Health Buddy system monitoring technologies automate data collection to allow healthcare providers to proactively manage, educate, and track a patient’s chronic condition. Clinical and patient information is securely transmitted and stored in databases, allowing evaluation of clinical measures and outcomes by health care professionals using Internet-enabled decision support tools. Medical devices such as those included in the recent 510(k) clearance connect to the Health Buddy appliance. Data collection from home medical devices is integrated into the system’s robust health management programs, enabling patients to receive personalized education and feedback about their meter readings, which are relayed to their healthcare professionals in chart format. The education and early intervention facilitated by the health management programs enables patients to become active members in their own care while enabling providers to increase quality of care and decrease costs.
About Health Hero Network
Health Hero Network develops and markets the Health Buddy® system for health improvement. The Health Buddy system serves as the interface between patients at home and care providers, facilitating patient education and monitoring of chronic conditions. The system includes monitoring technologies, clinical information databases, Internet-enabled decision support tools, health management programs and content development tools. Through increased communication, behavior modification, and prevention, the Health Buddy system improves the quality of care. Based in Mountain View, California, Health Hero Network’s systems are protected by over 55 issued US patents. http://www.healthhero.com.
