Vitls Inc. Announces FDA Clearance of Its Clinical-Grade Platform for Accurate and Continuous Vital Sign Monitoring in the Hospital and Home

Vitls Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Vitls Platform. The Vitls Platform utilizes a single device to continuously and remotely monitor the vital signs clinicians need to assess the status of patients in multiple healthcare settings — from the hospital to the home.

Vitls developed a clinical-grade platform that enables healthcare providers to reliably and accurately monitor key patient vital signs in real-time. The Vitls Platform consists of Tégo, a small and unobtrusive wearable that wirelessly records vital signs; the Vitls Cloud, where data is stored and then sent to hospital systems, the Vitls App and other connected devices; and the Vitls App, which displays the data in an intuitive layout.

Data collected with the Vitls Platform gives healthcare providers a complete picture of a patient’s status, paving the way for early intervention and improved outcomes. Studies show that deterioration can be identified and treated more than 60 percent earlier with continuous, remote monitoring.1

"Obtaining and managing patient vitals in a distributed environment can be challenging. The Vitls Platform, with its wearable device and accompanying software, offers a better chance for continuous, unobtrusive, remote monitoring, to better manage patient care in a multitude of scenarios,” said Stephen Meyer, former president & chief executive officer of Welch Allyn.

“We developed Tégo to address the challenge of intermittent monitoring and late detection for both patients and clinicians,” said Werner Vorster, chief executive officer and founder of Vitls Inc. “With this FDA clearance and our U.S. launch planned for Q3/2020, we are much closer to our goal of making continuous monitoring the standard of care in healthcare settings, as well as in the home. Healthcare needs accurate, clinical grade, continuous monitoring — especially now during COVID-19 — and we’re proud and fortunate to be in a position to help.”

About Vitls Inc.

Vitls Inc. is a digital healthcare company that focuses on remote monitoring of patient vital signs throughout the care continuum. The company developed the Vitls Platform which consists of the Tégo wearable, an unobtrusive patch that continuously collects vital signs and other data from the wearer, the Vitls Cloud where data is stored and then sent to hospital systems and/or any connected device as well as the Vitls App, which displays the data in an intuitive layout.

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305881/