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FDA OKs remote monitoring sensor powered by Mayo Clinic technology

September 11, 2012 11:49 am by | 1 Comments

Placement options for the BodyGuardian sensor.

Preventice, a  Minneapolis mobile health and remote monitoring company announced Monday that its BodyGuardian Remote Monitoring System has been cleared by the U.S. Food and Drug Administration.

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.

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Arundhati Parmar

By Arundhati Parmar

Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.
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