Devices & Diagnostics

Remote health monitoring system gets FDA 510(k) clearance

Ambio Health, a Stamford, Conn.-based company that specializes in health monitoring, received a Class II FDA 510(k) clearance for its Ambio Remote Health Monitoring System. With the intent of saving patients money, the device, which includes a wireless blood glucose monitor and wireless gateway (a blood pressure meter and weight scale, also FDA-approved, can be […]

Ambio Health, a Stamford, Conn.-based company that specializes in health monitoring, received a Class II FDA 510(k) clearance for its Ambio Remote Health Monitoring System. With the intent of saving patients money, the device, which includes a wireless blood glucose monitor and wireless gateway (a blood pressure meter and weight scale, also FDA-approved, can be added if the extra dough is coughed up), runs $44.97; then the patient must pay a monthly subscription rate of $4.99 to access the web-based portal where the information is stored.

The Ambio Remote Health Monitoring System logs health readings that can be viewed by family and caregivers online and is HIPAA compliant.

“Our goal at Ambio is to enable individuals to take health readings at home and get connected to healthcare providers, loved ones and caregivers who may not be able to visit every day,” CEO Kevin Jones said in a release.