Devices & Diagnostics

Remote monitoring firm with Mayo ties announces manufacturing partner

Minneapolis software company Preventice announced Monday that it is partnering with Avery Dennison Medical Solutions, which is will manufacture and sell its wearable body sensor once it is cleared by the Food and Drug Administration. The company, formerly called Boost Information Systems and based near Mayo Clinic in Rochester, has filed a 510(k) application for […]

Minneapolis software company Preventice announced Monday that it is partnering with Avery Dennison Medical Solutions, which is will manufacture and sell its wearable body sensor once it is cleared by the Food and Drug Administration.

The company, formerly called Boost Information Systems and based near Mayo Clinic in Rochester, has filed a 510(k) application for its miniature, remote body monitor called  BodyGuardian. Avery Dennison will build a version of this patch-based wearable sensor and sell it under the name of Metria, explained Colleen Kulhanek, director of corporate marketing, in a phone interview. (Although the 510(k) is for the device called BodyGuardian, since the product is not cleared yet, the name is not final, Kulhanek said.) The technology is partly based on Mayo’s intellectual property.

So how does this remote monitoring system work?

The device is worn underneath clothes next to the skin and is able to monitor heart rate, ECG, respiratory rate and physical activity, said Judy Eastman, Preventice’s director of product development and management, in an earlier interview. Designed to monitor nonlethal irregular heart rhythm, the BodyGuardian collects the physiological information and transmits it using wireless and smartphone technology to a physician who can monitor a patient remotely.

Earlier this year, another Preventice executive told a audience at a conference in New York that the final product will be as unobtrusive as a band-aid.

To make that device requires expertise that Preventice – a software and mobile app company – does not have. And that is what Avery Dennision brings to the partnership, especially with its experience in making adhesive materials for medical applications.

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The device also uses the Preventice Care Platform “which creates a real-time, continuous connection between patients and health care providers through mobile, cloud-based and sensor technology,: a company news release said.

However, before it can be sold, Metria will need to be cleared through an extension of the original 510(k) application of BodyGuardian that was filed in April, said Preventice’s Kulhanek. Aside from manufacturing Metria, Avery Dennison is also licensing proprietary algorithms from Preventice in order to develop its own  clinical applications of the technology.

Preventice’s sensor and remote monitoring technology incorporate know how from Mayo Clinic and Proteus Biomedical. In fact Preventice licensed certain algorithms and clinical practices from Mayo in November 2010 to develop BodyGuardian and Mayo has an equity stake in the company.

Currently,  heart rate, ECG, respiratory rate and physical activity are the four metrics are what the sensor can track today, it will have the technological capability to track other physiological functions in the future, Kulhanek said. That is why the plan is to have several designs of the products for a variety of customer.

“Our final, go-to-market plan is still being decided but the bottom line is we want to a come out with a full-feature remote monitoring technology with different cost and design options,” Kulhanek said. “With this announcement, we are broadening that ecosystem with a new partner.”