Ambio Health scored a green light from the FDA for its Ambio Remote Health Monitoring System, passing muster as a Class II device, the same category as wheelchairs and infusion pumps.
The at-home monitoring system is designed to keep tabs on vital signs for patients with high blood pressure, heart disease and diabetes. The information is relayed to healthcare providers and can also be viewed at home by the patient’s family members or caregivers.
The Stamford, Conn.-based company is slated to debut its device at the annual American Assn. of Diabetes Educators meeting in Philadelphia next week. Ambio said it the system will be sold at $49.97 per home unit with a $4.99 monthly maintenance charge.
"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," CEO Kevin Jones said in prepared remarks. "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."