Technology | Wearables | December 12, 2017

VitalConnect Secures Fifth FDA Clearance for Patient Monitoring Device

The VitalPatch wearable biosensor will include five-day wear duration in alignment with nation's average hospital stay

VitalConnect Secures Fifth FDA Clearance for Patient Monitoring Device

December 12, 2017 — VitalConnect Inc. announced its fifth 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the company’s existing Class 2 wearable biosensor, the VitalPatch. This clearance extends the wear duration for the VitalPatch by 25 percent from 96 hours (four days) to 120 hours (five days).

The national average for a patient length of stay in the hospital is 4.5 days, according to the Agency for Healthcare Research and Quality within the U.S. Department of Health and Human Services. With a wear duration that covers the average hospital stay, the VitalPatch biosensor is ideally suited for hospital patient monitoring; offering insight into patient health and providing potential cost savings for hospitals. The biosensor is a single-patient-use and fully disposable device, providing convenience for caregivers and comfort for patients. The device is also used beyond the hospital walls where continuous monitoring is needed, including post-discharge monitoring, remote patient monitoring and in clinical trials.

VitalConnect said the clinical-grade VitalPatch is the industry's smallest and lightest wearable biosensor that measures eight different biometric measurements continuously and in real-time. The eight patient measurements include: single-lead ECG (electrocardiography), heart rate, heart rate variability, respiratory rate, skin temperature, body posture, fall detection and activity (steps).

For more information: www.vitalconnect.com

Related Content

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en
heart disease image
News | Cardiac Diagnostics | December 18, 2019
December 18, 2019 — In their latest report, “...
FDA Warns Troponin Tests Impacted by Biotin Dietary Supplement
Feature | Cardiac Diagnostics | November 05, 2019 | Dave Fornell, Editor
November 5, 2019 — The U.S.
Videos | Cardiac Diagnostics | October 29, 2019
Doctor Clyde Yancy was a keynote speaker and said doctors need to check their assumptions about patients at the door...
79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event. Image courtesy of University Hospitals.

News | Cardiac Diagnostics | October 16, 2019
Health and wellness screenings are more than just nice events for the community – they can save lives. A Mentor, Ohio,...
Pesticide Exposure May Increase Heart Disease and Stroke Risk

Image courtesy of zefe wu from Pixabay

News | Cardiac Diagnostics | October 15, 2019
On-the-job exposure to high levels of pesticides raised the risk of heart disease and stroke in a generally healthy...
World Heart Federation Launches Global Roadmap on Cardiovascular Disease Prevention Among Diabetics
News | Cardiac Diagnostics | September 04, 2019
At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World...
Insomnia Tied to Higher Risk of Heart Disease and Stroke

Image courtesy of the American Heart Association

News | Cardiac Diagnostics | August 19, 2019
People suffering from insomnia may have an increased risk of coronary artery disease, heart failure and stroke,...