Intel Receives FDA Market Clearance on In-Home Medical Device for Management of Health Conditions

The Intel® Health Guide Connects Patients and Their Care Teams for Personalized Care Management at Home

Intel Corporation today announced the receipt of 510(k) market clearance from the U.S. Food and Drug Administration (FDA) on Intel’s personal health system, the Intel® Health Guide, a care management tool for healthcare professionals who manage patients with chronic conditions. The Intel Health Guide enables caregivers to provide their patients with more personalized care at home, while also engaging and empowering patients to take a more active and positive role in their own care.

“This is an important product that will improve the state and cost of health care around the world,” said Louis Burns, vice president and general manager of Intel’s Digital Health Group. “It results from years of research to understand the needs of the aging population and how technology can support them in their daily lives. With more people living with chronic diseases, we believe care can be increasingly moved outside of the hospital to the home. Through our research, we’ve learned that a home-based model of care becomes more than just delivering care to patients at home – it is about creating connections to family, friends, caregivers, and the care team.”

The Intel Health Guide is a comprehensive solution, combining an in-home patient device, as well as an online interface allowing clinicians to monitor patients and remotely manage care. The solution offers interactive tools for personalized care management and integrates vital sign collection, patient reminders, multimedia educational content and feedback and communications tools such as video conferencing and e-mail. The Health Guide can connect to specific models of wired and wireless medical devices, including blood pressure monitors, glucose meters, pulse oximeters, peak flow meters and weight scales. The Health Guide stores and displays the collected information on a touch screen and sends to a secure host server, where health care professionals can review the information. Patients using the Health Guide can monitor their health status, communicate with care teams and learn about their medical conditions.

“We believe the Intel Health Guide represents a new category of personal health systems that goes beyond the simple remote patient monitoring devices available today,” Burns said. “We envision a wide range of usage models, not only chronic conditions such as CHF and diabetes, but also programs for health and wellness management at home.”

Intel has completed pilot studies in the United States and United Kingdom to facilitate patients’ and clinicians’ understanding of the Intel Health Guide. Later this quarter, Intel will conduct additional pilots with health care organizations to understand how the guide integrates with different care management models in the home. Intel expects the guide will be commercially available from health care providers in the US and UK in late Q4 2008 or early Q1 2009.