Authors: Katheryn Hope Wilkinson and Kate Lak, MD
Vitls Inc received FDA approval for Tégo and the Vitls Platform in July of 2020.
The Vitls Platform is a wireless physiologic monitoring system that collects data from a remote patient sensor. The Tégo VSS sensor, as a component of the Vitls Platform, is a waterproof patch that measures physiologic parameters such as heart rate, temperature and pulse oximetry. It is a wireless, disposable, battery-powered patch that lasts 5 days and transmits the information to the Vitls Platform when in range. The patch itself can hold data for 3 hours when the patient is outside of range until connectivity resumes.
Data tracked by the Vitls Platform includes heart rate and temperature. It includes cloud storage software as well as an app, which can be used to review the data remotely by patients and their medical teams. The information is intended to be used for retrospective analysis for diagnosis and treatment. It is not intended for active monitoring of patients.
The FDA has determined the Vitls Platform is substantially equivalent to the predicate device Isansys Lifecare Ltd. Patient Status Engine (K172329). The Vitls Platform and the Patient Status Engine are both wireless physiological monitors which transmit data to a remote data collection system. Both systems transmit data on heart rate and temperature whereas the Patient Status Engine contributes additional data, often with optional third-party accessories.
The thermometer feature of the Vitls Platform is additionally supported by another predicate device, the Vivalnk FeverScout (K162137).
Performance testing confirmed standards of safety and efficacy were met. This testing included biocompatibility testing, electrical safety testing, compliance with body temperature monitoring performance, electromagnetic compatibility testing and heart rate monitoring performance compared to GE Medical Systems Information Technologies Dash 5000 Patient Monitor (K073462).
The FDA has approved Tégo and the Vitls Platform use for:
- Patients at home and in the hospital.
- Patients who are older than 2 years old.
Tégo and the Vitls platform are not approved for use:
- In Critically ill patients
- In place of standard vital sign monitoring
