The miniature device, worn underneath the clothes next to the chest, monitors heart rate, ECG, respiratory rate and physical activity and transmits the data to a physician. The BodyGuardian is designed to monitor nonlethal irregular heart rhythm.
Preventice licensed the algorithms and clinical practices from Mayo Clinic in November 2010, and Mayo holds equity in Preventice, said Suzanne Leafbrock, a Mayo spokeswoman previously.
“We are thrilled that the FDA has provided clearance for the BodyGuardian RMS enabling Preventice to bring to market a real-time, remote connection between physicians and patients,” said Jon Otterstatter, co-founder, president and CEO of Preventice, in a news release. “Our vision at Preventice has been to maximize this industry-leading collaboration into a solution that enables healthcare providers to extend and improve care for their patients, where they live.”
The product will need to be prescribed by a physician or other health professional for either diagnostic purpose or following surgery.
The company expects the BodyGuardian RMS to be available by the end of the year.