Ambio Finds Remote Diabetes Health Monitoring Sweet Spot With FDA Nod

Monitoring specialist Ambio Health, has announced that its wireless remote health and activity monitoring tool, has received Class II FDA 510(k) Clearance.


The Ambio Remote Health Monitoring System crosses the divide between professional and consumer healthcare. To prove the point, it 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.”

So why is it featuring on our pages?

Well, take a look at the comments from physicians and you’ll see the benefit they perceive in a device that not only provides home health readings for patients and caregivers, but also provides accurate and complete readings to health care providers for the regular monitoring of patient health. What’s more, it has the ability to set individualized alert levels and notifications of exception conditions and can be set up with individualized reminders for readings and medications that can be sent to the patient via telephone call, text message or email

Physician comments

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.”

Company comments

“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.”

Yours for only..

Just to reemphasise the consumer nature of this system, the company release includes pricing. A single device starts at $49.97, which includes a wireless glucose meter. 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.

Source: Ambio Health, Business Wire