Ambio Health, a provider of health monitoring systems, has received 510(k) clearance from the US Food and Drug Administration for its Ambio Remote Health Monitoring System, a wireless remote tool that helps patients monitor high blood-pressure, heart disease and diabetes at home.
Ambio Health CEO Kevin Jones said that the company’s goal is to enable individuals to take health readings at home and get connected to health care providers, who may not be able to visit every day.
"We are very pleased to have realised 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," Jones said.
Launched in January 2013, the Ambio Remote Health Monitoring System provides accurate readings at home and these readings can be seen by caregivers through web-based Ambio Care Portal.
The readings enable doctors to monitor the health condition regularly, evaluate the pattern and make necessary changes.
The system has the capability to set individualised alerts and notifications of exception conditions.
Reminders for readings and medications can be sent through telephone call, text message or email to patients.
In addition, it can work with several health monitors and as a HIPAA compliant tool, health information is claimed to remain private and secure.
Weill Cornell Physicians’ Dr Jason C Baker said that Ambio provides 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 personalised to meet the needs of individual patients and providers," Dr Baker said.