Ambio Health lands 510(k) for home-based patient monitoring and data sharing
The FDA grants Ambio Health regulatory approval for the self-named remote patient monitoring system.
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.