Home monitoring system for heart patients gets FDA approval

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Doctors will soon be able to monitor a patient's heart beat after they've left the hospital thanks to a new wearable monitor system developed in Rochester in collaboration with Mayo Clinic.

The BodyGuardian Remote Monitoring System, a series of small wearable monitors created by Preventice with Mayo Clinic, got Food and Drug Administration approval Monday to be used by doctors to track non-lethal arrhythmia or irregular heart beats. The monitors are paired with a dedicated cell phone that allows doctors to check on a patient's heart rate at any time through a secure web site on their computers or via their iPad tablets.

"This is Preventice's single biggest milestone as a company. It's something we've been working toward for two years," says Michael Emerson, Preventice's senior vice president of marketing.

The device tracks a patient's breathing and movement as well as their heart beat to give doctors a complete picture of what is going on, even though the patient is at home.

It is expected to be commercially available by the end of the year, which means doctors will be able to prescribe it as a patient is released from the hospital and continue to monitor their condition.


The devices are expected to be manufactured in Europe and then set-up with software by Preventice in Minnesota. Emerson said the firm has not really begun to talk to hospitals and care facilities about contracting the BodyGuardian system yet, though marketing is expected to start this year.

Mayo Clinic, as the main collaborator that helped develop the system, will certainly have first priority as a customer, he said.

Preventice's BodyGuardian could help reduce the length of hospital stays, which could reduce the cost of health care, says Emerson. And it could improve a patient's recovery in a way that is less invasive than being treated in a medical facility.

"Health care today is very well-orchestrated, right up until the moment you walk outside of hospital," he said. "This technology can help with that transition, both in having it happen earlier and in having it show better success."

Mayo Clinic officials believe BodyGuardian will be a very effective tool.

"This platform has the potential to positively impact health-care outcomes," said Dr. Charles Bruce, a Mayo Clinic consultant in cardiovascular diseases and internal medicine, in the Preventice's announcement about the FDA approval.

Preventice is headquartered in Minneapolis and its main research and development site is in Rochester on West Circle Drive. It also works closely with Mayo Clinic, which holds a financial stake in the company.

The 5-year-old Preventice started out as Boost Information Systems in Rochester, before evolving into its current form. Preventice has created a number of health-related phone apps in conjunction with Mayo Clinic as well as building its own health data platform to keep patients and care providers connected and engaged.


Besides its facilities it Rochester and Minneapolis, Preventice also has an office in Fargo, N.D.

Emerson said the growing company has between 50 to 100 employees at the moment.

This health care niche of remote monitoring is growing rapidly and is expected to be fueled by the need to care for the country's rapidly aging population.

Experts anticipate almost 5 million patients will be using some type of wireless monitoring like this by 2016. The global market for this estimated to be worth more than $9 billion by 2014.

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