STAMFORD, Conn.--(BUSINESS WIRE)--Ambio Health, a healthcare technology company specializing in health monitoring systems, today announced that its Ambio Remote Health Monitoring System, a wireless remote health and activity monitoring tool, received Class II FDA Clearance 510(k). The company will be demoing the product, which can track health information for patients with high blood pressure, heart disease and diabetes, at the 2013 American Association of Diabetes Educators Annual Meeting, held from August 7-10, 2013 at the Pennsylvania Convention Center in Philadelphia, PA.
“Our goal at Ambio is to enable individuals to take health readings at home and get connected to health care providers, loved ones and caregivers who may not be able to visit every day,” said Kevin Jones, chief executive officer at Ambio Health. “We are very pleased to have realized the important milestone of FDA 510(k) clearance so quickly as it means we will be able to make this product readily available to those who need it.”
The Ambio Remote Health Monitoring System was launched in January 2013 at the Consumer Electronics Show and named as one of eWeek’s “10 Health and Fitness Tools To Track Exercise, Chronic Conditions.”
The Ambio Remote Health Monitoring System offers patients:
- Home health readings that are automatically logged and can be viewed by family members and caregivers from the secure, web-based Ambio Care Portal
- Accurate and complete readings which are available to health care providers for the regular monitoring of patient health
- The ability to set individualized alert levels and notifications of exception conditions
- Individualized reminders for readings and medications that can be sent to the patient via telephone call, text message or email
- An affordable system designed to work with a number of health monitors
- A HIPAA compliant tool that keeps health information private and secure
The system’s price starts at $49.97 for a single device, which includes a wireless glucose meter, and the user then pays an annual subscription that is the equivalent of $4.99 per month. Additional devices with wireless connectivity include a blood pressure meter and a weight scale and can be added a-la-carte.
Dr. Jason C. Baker, MD with Weill Cornell Physicians, notes: “Unlike competitors who just focus on glucose levels, Ambio is uniquely designed to also provide an interface on the critical measures of blood pressure and weight, which are key pieces in controlling the diabetes puzzle. The Ambio dashboard provides a comprehensive, yet straight-forward, overview of glucose control, and can be personalized to meet the needs of individual patients and providers.”
Adds Joy Pape, RN BSN CDE WOCN CFCN FAADE, an internationally-known Certified Diabetes Educator in New York City: “Over the last few months, I have been recommending the use of Ambio Remote Health Monitoring System to patients who have high blood pressure, heart disease or diabetes. By providing patients with a way to effortlessly take readings at home which can then be transmitted wirelessly, their caregivers – whether they be family members and/or health care providers – are alerted immediately to any abnormalities that might indicate a change in care for the patient.”
Pape continued: “The Ambio system shortens the amount of time I spend with my patients just finding, recording, or downloading their numbers in a manner that I can make sense of. Ambio allows me to spend more time with my patients looking at patterns, evaluating their health and making necessary changes.”
For more information, or to schedule a demo of the product, contact Kevin Jones at kevin.jones@ambiohealth.com or 973-568-0323, or visit www.ambiohealth.com.
About Ambio Health
Headquartered in Stamford, Connecticut, Ambio Health’s mission is to help people live better in their own homes. The company’s patent-pending technology provides the most affordable and easiest-to-use wireless health and activity monitoring solution available.
The Ambio Remote Health Monitoring System wirelessly sends readings from devices such as blood pressure and blood glucose meters and a weight scale to the web-based Ambio Care Portal where they can be viewed by patients and their authorized care partners.
For more information, visit www.ambiohealth.com.
INDICATIONS FOR USE
The Ambio Remote Health Monitoring System (“System”) consists of Ambio Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters, and the Ambio Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal (“Care Portal”). The Care Portal is used by patients and their caregivers (“Users”) to view readings, set reminders to take meter readings and pills, to set reading thresholds which will trigger alert messages and to set who will get reminder and alert messages. Reading history can be printed or exported. Users can set goals and rewards for taking readings and for keeping readings in target ranges. A patient survey tool can be used to gather qualitative health information. There is also has a shared calendar and message board to coordinate among Users. General health information from accredited sources is also available.
Ambio Wireless Connectors connect to the USB port on the meter, read the meter log, and wirelessly transmit encrypted readings to the Ambio Gateway. Ambio Wireless Connectors do not alter the indicated use of the describe meters. The Ambio Scale is a step on weight scale with an embedded Ambio Wireless Connector module to transmit weight readings in a similar manner. The Ambio Gateway connects to the patient’s existing internet broadband router and communicates the encrypted meter readings through to the Ambio Care Portal. Wireless transmission uses the ISM 900MHz frequency and devices comply with FCC regulations.
The Ambio Remote Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
