Vital Connect’s HealthPatch MD Biosensor Receives FDA Clearance

Vital Connect has received U.S. Food and Drug Administration (FDA) clearance for use of its HealthPatch MD biosensor for home monitoring of patients.

HealthPatch MD can be used to monitor patients with chronic conditions, for short-term monitoring after a patient is discharged from a hospital or as part of the follow-up care provided after a non-critical emergency room visit, company bigwigs noted. There were more than 129.8 million emergency department visits in 2010 according to the Center for Disease Control (CDC), but only 17.2 million of those visits resulted in an admission. In discharge or non-admittance situations healthcare professionals can prescribe HealthPatch MD as part of a follow-up treatment program.

In chronic care situations, HealthPatch MD enables home health care professionals to monitor patients on a 24-hour basis. In addition to checking vital signs during scheduled visits, health care professionals will now be connected to their patients between visits, Vital Connect executives said. HealthPatch MD 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.

Statistics from the CDC indicate more than 1.5 million Americans are the recipients of home health care services with an average length of care of 315 days. The Centers for Medicare & Medicaid Services projects that home health care costs for 2014 will reach $86.8 billion.

Encapsulated within the HealthPatch MD are sensor and electronics technologies. Combined with Vital Connect’s proprietary algorithms, these technologies enable the device to provide clinical-grade measurements of the following core health metrics: single lead ECG, heart rate, heart rate variability, respiratory rate, skin temperature, posture including fall detection and severity, and steps. Company officials claim the HealthPatch MD is the first FDA-cleared medical device that includes a fall detection feature.

“Receiving FDA clearance for HealthPatch MD to be used in home care settings is an important milestone for the future of the healthcare industry,” said Vital Connect CEO Nersi Nazari. “Medical professionals will soon be able to provide unparalleled service to their home care patients because the HealthPatch MD will allow them to know if a patient’s heart rate or respiratory rate, for example, crosses a predetermined threshold and react accordingly. And, bulky machines that interfere with daily activities will no longer inhibit a patient’s normal routine. 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 weighs 10 grams and is 6 mm (0.24 inches) thick. The data reporting may be customized by a healthcare professional to meet the needs of an individual patient, according to Vital Connect; the sensor uses 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.

The HealthPatch MD has received regulatory approval (CE Mark) for distribution in Europe, and is licensed and registered by Health Canada for distribution in Canada. 

Vital Connect is a Silicon Valley-based company founded in 2011 with the goal to develop technologies that help address some of the most challenging healthcare issues in the world today. Vital Connect creates wireless, wearable biosensors that are small, powerful, and capable of capturing clinical-grade biometric measurements in a continuous, configurable and non-obtrusive manner.