Remote monitoring system approved by FDA
The Ambio Remote Health Monitoring System, a wireless remote health and activity monitoring tool developed by Ambio Health, a healthcare technology company specializing in health monitoring systems, has 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.
“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,” says Kevin Jones, CEO of 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.”
Ambio’s remote 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. Readings are also available to healthcare providers for the regular monitoring of patient health. The system offers the ability to set individualized alert levels and notifications of exception conditions, as well as individualized reminders for readings and medications that can be sent to the patient via telephone call, text message, or email. Patients can invite family and professional care partners to join their “care circle” – which allows those providing support to the patient to access the data and view results. Members of the care circle can also set up reminders for the patient to take readings and medications, as well as create a points and rewards system for achieving targets.
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. The system is plug-and-play with just a broadband internet connection required to work, and has a range of about 5,000 square feet.
“Industry studies show that 90 percent of seniors aged 65 and up would like to ‘age in place,’ but since most of them have chronic diseases, family members are concerned about their health status, especially when they are not able to visit every day,” Jones says.”Surveys show that a large percentage of seniors aged 65 and up and their families would use remote health monitoring if made affordable. In addition, numerous studies have shown that remote health monitoring reduces expensive hospitalizations and ER visits for chronic diseases such as heart disease, lung disease and diabetes. However, most remote health monitoring solutions can only be cost-justified for those most at risk of hospitalization.”
According to the PricewaterhouseCoopers’ Health Research Institute “Healthcare Unwired” report, 88 percent of physicians would like their patients to be able to track and/or monitor their health at home, with the greatest interest in monitoring weight, blood sugar and vital signs (blood pressure, heart rate respiratory rate). The American Heart Association recommends home monitoring for all people with high blood pressure to help the healthcare provider determine whether treatments are working.
Ambio was founded in 2011 by Jones and Alden Stevens. Jones was a partner in Accenture, the global IT consulting company, and worked with clients in consumer electronics, software, telecommunications and distribution. Stevens was chief information officer of Reynders, Gray & Co., Inc. an investment management company in New York.
“We founded Ambio because we saw that chronic diseases like diabetes and hypertension affect tens of millions of people in this country and are drivers of a majority of health care costs in the United States, and we knew we could develop an innovative solution for the chronic disease and the related ‘aging in place’ markets,” Jones says. “We saw how remote patient monitoring can be used to improve how healthcare is delivered, but that existing solutions were much more expensive and complex than they needed to be. We endeavored to create a solution that was so affordable that it would be cost beneficial to use with the majority of people with chronic diseases, while at the same time being simple, safe, reliable and secure.”
Posted: August 2013