VitalConnect, Inc. issued the following announcement on May 5.
VitalConnect®, Inc., a leader in wearable biosensor technology, announced it was granted Emergency Use Authorization (EUA) status by the U.S. Food and Drug Administration (FDA) as part of the response to the COVID-19 pandemic. The FDA EUA will further enhance the capabilities of the VitalPatch and continuous patient monitoring technology, the Vista Solution.
Under the FDA EUA, the VitalPatch is now authorized to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Drugs such as Hydroxychloroquine and Chloroquine, being used to treat COVID-19, can cause prolongation of QT intervals for patients and may lead to life-threatening arrhythmias. VitalConnect QT interval detection capabilities help enable clinicians to remotely and continuously monitor patients in real-time who may have, or develop, an elongation of QT interval as a result of their COVID-19 treatment.
Founded in 2011, VitalConnect has deployed over 100,000 patches across the world, including care facilities such as Hackensack Medical Center and John Radcliffe Hospital-Oxford University. This EUA status from the FDA comes at a crucial time when patients need access to continuous, real-time monitoring the most, and VitalConnect's unique vital sign and cardiac monitoring solution provides the information necessary to help save lives.
"COVID-19 presents a myriad of symptoms and clinicians need access to medical devices that allow them to monitor and manage those symptoms in real-time in order to create the most appropriate treatment plans for each individual," said Dr. Joe Roberson, Chief Medical Officer of VitalConnect. "The enhancement of the VitalPatch receiving Emergency Use Authorization for QT-interval detection will enable this platform to further support clinicians who are on the frontlines of treating this virus."
As clinicians recognize and analyze the impact of COVID-19 on the heart, the ability to monitor other key vital signs provides critical information needed to develop effective treatment plans. Vista Solution, with the VitalPatch and optional 3rd party devices, measures 11 physiological vitals continuously and in real-time including body temperature, heart rate, heart rate variability, respiratory rate, and blood oxygen saturation levels. The VitalPatch is the first and only biosensor capable of monitoring such a broad set of patient vitals as well as detecting QT interval changes.
"As we learn more about the novel coronavirus, the VitalPatch and Vista Solution platform can make a big impact on the treatment of the many people suffering across our nation," said Peter Van Haur, CEO, VitalConnect. "Continuous, real-time monitoring enables next-level care and efficiency in the hospital and in post-discharge settings that will help clinicians treating patients on the frontlines today."
About VitalConnect, Inc.
VitalConnect is a leader in wearable biosensor technology for wireless patient monitoring in both hospital and remote patient populations. VitalConnect leverages extensive expertise in biomedical engineering, data analytics, chip design, and mobile and cloud software to create technology that supports decision-making paradigms that achieve better health and economic outcomes. VitalConnect's products are designed for use in a broad range of inpatient and outpatient settings, such as hospital monitoring, post-discharge care, cardiac monitoring and pharmaceutical solutions. For more information: www.vitalconnect.com.
About Vista Solution
The Vista Solution incorporates four primary components: the VitalPatch clinical grade biosensor, a Vista Tablet, the VitalCloud, and the VistaCenter central monitoring station. Through the Vista Solution, clinicians can monitor up to 11 different patient vitals in real-time including those captured by the VitalPatch (single-lead EKG, heart rate, heart rate variability, respiratory rate, body temperature, body posture, fall detection, activity) and those captured by 3rd party devices (blood oxygen, weight, blood pressure). COVID-19 patients suffer from a variety of symptoms including respiratory distress, low blood oxygen levels, and QT prolongation, which can all be monitored with the Vista Solution. The VitalPatch is a disposable, band-aid sized wearable, each with a 7-day battery life.
About the Emergency Use Authorization
VitalConnect submitted the EUA request under the agency's January 2017 "Guidance for Emergency Use Authorization of Medical Products and Related Authorities," which enhances FDA's authority to support emergency preparedness and response and foster the development and availability of medical products for use in public health emergencies. For more information on VitalConnect's EUA including indications for use, visit the FDA's website here.
Original source can be found here.
