HealthPatch MD biosensor receives FDA clearance

Vital Connect has received FDA clearance for use of its HealthPatch MD biosensor for monitoring patients in their homes. As an industry pioneer of wearable biosensor technology, Vital Connect enables medical professionals to stay connected to patients in the clinic and at home.

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. There were over 129.8 million emergency department visits in 2010 according to the Centre 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. HealthPatch MD will make 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 are cutting-edge 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. The HealthPatch MD is also said to be 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 only 10g and is only 6mm (0.24”) thick. This light and thin form factor is comfortable for patients and less obtrusive than conventional monitoring equipment. The data reporting may be customized by a healthcare professional to meet the needs of an individual patient. 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 EU, and is licensed and registered by Health Canada for distribution in Canada.