|[August 28, 2014]
Vital Connect HealthPatchTM MD Biosensor Receives FDA Clearance for Monitoring Patients at Home
SAN JOSE, Calif. --(Business Wire)--
Vital Connect announced today that it received FDA clearance for use of
its HealthPatchTM 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.
HealthPatchTM 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 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 HealthPatchTM MD as part of a
follow-up treatment program.
In chronic care situations, HealthPatchTM 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.
HealthPatchTM 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
According to the latest statistics from the CDC, over 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
Encapsulated within the HealthPatchTM MD are cutting-edge
sensor and electronics tchnologies. 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 HealthPatchTM MD is also 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 HealthPatchTM MD weighs only 10 g and is only 6 mm
(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 HealthPatchTM MD has received regulatory approval (CE
Mark) for distribution in EU, and is licensed and registered by Health
Canada for distribution in Canada. For more information on the
HealthPatchTM MD and to explore ways this new technology can
be incorporated into various healthcare settings to transform the
landscape of treatment delivery, visit: www.vitalconnect.com.
Note: The HealthPatchTM MD is referred to as the VitalConnect
Platform in the 510(k) and Technical File.
About Vital Connect, Inc.
Vital Connect is a growing Silicon Valley-based company founded in 2011
with the goal to develop the newest generation of technologies that help
address some of the most challenging healthcare issues in the world
today. Vital Connect's extensive expertise enables the company to create
wireless, wearable biosensors that are small, powerful, and capable of
capturing clinical-grade biometric measurements in a continuous,
configurable and non-obtrusive manner. Through various partnerships,
Vital Connect solutions will be available for use in hospitals, research
facilities, doctor's offices, care facilities and homes. For more
information, visit: www.vitalconnect.com.
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