FDA OKs remote heart monitor

A Minnesota-made remote monitoring system that transmits patients' heart rhythms over a cellphone and allows doctors to review the data on their iPads has received approval by federal regulators.

Developed in collaboration with Mayo Clinic, the BodyGuardian Remote Monitoring System allows remote observation of individuals with cardiac arrhythmias. The technology will allow physicians to monitor their patients' ECGs, heart rates, respiration rates and activity level while they go about their daily lives, Preventice said Monday.

The system is not yet available over the counter. But its maker, PreventiceTM Inc., a Minnesota company that develops mobile health applications, expects that to happen by the end of the year. Officials said Monday they will immediately begin selling the technology to hospitals and clinics.

A small body sensor attached to a patient's chest transmits data through a specially programmed, secure cellphone to a monitor. The data then is made available to the patient's doctor, who can access the data at the office or while on the go.

Although not yet commercially available, the BodyGuardian RMS will be prescribed by a physician when diagnostic and post-procedure monitoring is needed.

"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. "Our vision at Preventice has been to maximize this industry-leading collaboration into a solution that enables health care providers to extend and improve care for their patients, where they live."

The monitoring system is the first device Preventice is selling as its own product. Up until now, the private company has done contract engineering and software development for other companies. Preventice intends to sell the system in the United States and Europe. It has operations in Minneapolis, Rochester and Fargo, N.D.

"The view that is out there is if we want to lower health care costs, we cannot continue to wait until something goes wrong and then go to the doctor to see if it can be fixed," Gunderson said. "And the FDA is showing an increasing willingness to approve these kinds of products. But the question to be answered is: Who will pay for it?"

Gunderson said the upside of such technology is only limited by the ability of the health care system to persude insurance companies and other payers of the benefits.

"Whoever cracks that code is going to go to the moon," he said.

The company declined to discuss pricing for the device.

Another challenge for remote monitoring is privacy and security, said Michael Emerson, a Preventice senior vice president. BodyGuardian has a secure data-exchange platform that disconnects any identifying information from heart rhythm data, transmits it and then reconnects it to the doctor's system, Emerson said. "Our technology secures the information," he said.

"We had a vision of ... being able to identify problems before they occur," he said. "And, if they do occur, how could we help patients live more easily with the problems that they face?"

The system is approved for use with people who may have irregular heartbeats, but can otherwise get around. Bruce, who has worked on the idea since 1999 with a team that includes engineer Kevin Bennet, Dr. Virend Somers and Dr. Paul Friedman, said the technology is meant to be a type of early warning system.

"This is an exciting opportunity and an example of how we are having to look at the delivery of health care differently," he said.

Preventice said wireless monitoring is becoming more common. According to a recent study, an estimated 2.2 million patients worldwide are using this type of technology. Berg Insight analysts anticipate wireless monitoring will involve 4.9 million patient connections by 2016. In addition, Technavio estimates the global patient monitoring market will reach $9.3 billion by 2014, Preventice said.