Tech Company Earns FDA Clearance for Home Health Monitoring Patch

A Silicon Valley company specializing in healthcare technologies recently received clearance from the U.S. Food and Drug Administration (FDA) for use of its biosensor patch that monitors patients’ health in their homes.

Vital Connect’s HealthPatch MD enables medical professionals to stay connected to patients in the clinic and at home on a 24-hour basis. In addition to checking vital signs during scheduled visits, health care professionals are also connected to their patients between visits.

HealthPatch MD can be used to monitor patients with chronic conditions, for short-term monitoring after a patient is discharged from the hospital or as part of the follow-up care provided after a non-critical emergency room visit.


The device also makes it possible for caregivers to receive notifications on changes in patient conditions when physiological data falls outside selected parameters via a smartphone or other device.

Encapsulated within the HealthPatch MD technology are sensor and electronics technologies that, combined with Vital Connect’s proprietary algorithms, enable the divide to provide clinical-grade measurements of a variety of metrics.

Core health metrics the tech is able to track include single lead ECG, heart rate, heart rate variability, respiratory rate, skin temperature, posture, including fall detection and severity, as well as an individual’s steps.


HealthPatch MD will enable medical professionals to know if a patient’s heart rate or respiratory rate, for example, crosses a predetermined threshold, thus enabling them to reach accordingly, says Vital Connect CEO Nersi Nazari.

With over 1.5 million Americans receiving home health care services and costs projected to reach $86.8 billion in 2014, according to data from the Center for Disease Control and the Centers for Medicare & Medicaid Services, sensor technology like that can be used in the home care setting is an important milestone for the future of healthcare, Nazari said.

Weighing only 10g and 6mm thick, the HealthPatch MD device aims to deliver a less cumbersome solution to monitoring patient health at home. Sensors within the device use Bluetooth 4.0 to connect to a relay or smartphone and the relay transfers information by Wi-Fi to the cloud meeting HIPPA and cyber security guidelines.

“Bulky machines that interfere with daily activities will no longer inhibit a patient’s normal routine,” Nazari said in a written statement. “Monitoring will occur seamlessly and will not interfere with a patient’s routine at home, work or leisure. Patients will have confidence that their condition is being monitored by a healthcare professional outside of the healthcare setting.”

The HealthPatch MD received regulatory approval for distribution in Europe and is licensed and registered by Health Canada for distribution in the country.

Written by Jason Oliva

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