Vitls

by Vitls Inc.  · Based in United States → — Monitor Vitals 24/7.
Critical Care Hospital Medicine Internal Medicine
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Regulatory Status Disclosed

Overview

Vitls Inc. offers a wireless remote monitoring system with cloud-based data analysis that provides continuous physiological data. The Vitls Platform consists of Tégo, a small, unobtrusive, flexible, waterproof, and disposable wearable device with a 5-day battery life, which continuously records vital signs such as body temperature, pulse rate, heart rate variability, respiration rate, blood oxygen levels (SpO2), and activity (including fall detection). The data is sent to the Vitls Cloud, where algorithms convert it into actionable intelligence, and then made available to clinicians via the Vitls App and can be integrated with hospital EHR systems. This enables clinicians to view vital sign trends, receive instant notifications, and make informed decisions, aiming to improve patient outcomes, shorten hospital stays, and enhance patient satisfaction by making continuous vital sign monitoring the standard of care in various healthcare settings, from hospital to home, for patients 2 years and older.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Unobtrusive, flexible, waterproof, disposable Tu00e9go wearable device
  • Wireless vital sign monitoring
  • 5-day battery life for continuous monitoring
  • Continuous data collection (temperature, pulse rate, HRV, respiration rate, SpO2, activity/fall detection)
  • Cloud-based data analysis and actionable intelligence
  • EHR system integration
  • Vitls App for clinicians and patients
  • Live dashboard for real-time data
  • Instant notifications for vital sign changes
  • Patient data trends and history viewing

Use Cases

  • Postoperative care monitoring to assess complication risk and shorten hospital stays
  • Emergency room triage and efficient patient assessment
  • Continuous monitoring for clinical trial participants
  • Remote patient management from hospital to home
  • Chronic disease management
  • Reducing healthcare worker exposure to infectious patients (e.g., COVID-19)

What Physicians Need to Know

Evidence Base
Vitls Platform received FDA 510(k) clearance in July 2020, signifying its classification as a clinical-grade platform for continuous and remote vital sign monitoring. Performance testing confirmed safety and efficacy standards, including biocompatibility, electrical safety, electromagnetic compatibility, and heart rate monitoring accuracy against predicate devices. The data collected is intended for retrospective analysis to aid diagnosis and treatment.
Clinical Validation Studies
The Vitls Platform underwent performance testing against predicate devices such as the Isansys Lifecare Ltd. Patient Status Engine and Vivalnk FeverScout, and the GE Medical Systems Information Technologies Dash 5000 Patient Monitor for heart rate. A feasibility study (NCT05245747) is evaluating the collection of physiologic data and its fit with heart rate, respiratory rate, temperature, and oxygen saturation in pediatric populations compared to standard monitoring.
Alert Fatigue Management
The Vitls Platform is designed to notify clinicians when vital signs data fall outside configured ranges. By providing continuous data and 'actionable intel,' the system aims to focus alerts on critical changes, potentially reducing non-actionable alarms and contributing to better alarm management.
Clinical Workflow Integration
Vitls streamlines care by eliminating manual, intermittent vital sign checks and data entry, syncing patient data directly into the EHR system. It offers a live dashboard, instant notifications, patient data trends, and the ability to add notes, enhancing efficiency and enabling timely decision-making.
Decision Audit Trail
The Vitls Platform stores collected vital signs data in the cloud, managed by a Secure Server Library, making it available for review and analysis by clinicians, qualified personnel, and researchers. This comprehensive data storage inherently supports a detailed record of patient physiological parameters over time.
Physician Tip

Leverage Vitls for continuous, real-time vital sign monitoring to proactively identify patient deterioration and intervene earlier, especially in postoperative care, emergency room triage, and for patients with chronic conditions. Utilize the trend data and 'actionable intel' to gain a holistic view of patient status beyond intermittent snapshots, facilitating more informed diagnosis and treatment decisions. Integrate the system into existing EHR workflows to reduce manual charting, minimize errors, and free up nursing time for direct patient care.

Vitls is compatible with iOS, Android, web browsers, and many EHR systems, allowing for seamless data synchronization via the cloud. This capability enables real-time patient vital sign data to be converted into actionable intelligence within existing hospital systems or the Vitls dashboard, supporting a unified clinical workflow.

Details

Category Clinical Decision Support & Reference, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Vitls Platform received 510(k) clearance from the U.S. FDA in July 2020 for continuous and remote monitoring of vital signs including heart rate, heart rate variability, respiration rate, blood oxygen levels (SpO2), body temperature, and activity (including fall detection) for patients 2 years of age or older in hospital and home settings.
Integrations
EHR Not specified
Specialties Critical Care, Hospital Medicine, Internal Medicine

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Press & Coverage

Vitls
Vitls Inc. Announces FDA Clearance of Its Clinical-Grade Platform for Accurate and Continuous Vital Sign Monitoring in the Hospital and Home
Vitls Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vitls Platform, a clinical-grade system for continuous and remote vital sign monitoring in both hospital and home settings. The platform includes a wearable device called Tu00e9go, the Vitls Cloud for data storage, and the Vitls App for data display.
2020-07
BreakingMED
FDA OKs Remote Patient Monitoring Platform
The FDA approved the Vitls Platform for remote, real-time monitoring of patient vital signs in various healthcare settings, including hospitals and homes. This approval aligns with the growing trend of wearable health devices and the FDA's revised guidance for non-invasive remote monitoring during the COVID-19 pandemic.
2020-07
Vitls
Vitls is Developing Small, Disposable, and Unobtrusive Wearables
Vitls has developed a small, flexible, waterproof, and disposable wearable monitor with a six-day battery life, designed for unobtrusive and continuous vital sign monitoring. The goal is to provide a better solution than current bulky hospital monitors, with potential applications for chronic disease patients and clinical studies from home.
2020-07
Vitls
Vitls, Inc. to Join KidsX, the Largest Pediatric-Focused Digital Health Accelerator in the World
Vitls Inc. was accepted into KidsX, an international consortium of pediatric hospitals dedicated to improving digital health innovation. This move highlights Vitls' focus on pediatric solutions for unobtrusive, continuous, and remote vital sign monitoring.
2021-01
accessdata.fda.gov
510(k) Premarket Notification - Vitls Platform
This FDA 510(k) premarket notification details the Vitls Platform, a wireless remote monitoring system for continuous collection of physiological data (heart rate and body temperature) in healthcare and home settings. The document outlines its intended use for patients aged 2 years or older and its substantial equivalence to predicate devices.
2020-06
Vitls
Vitls & COVID
Vitls highlights how its platform can transform COVID care by enabling continuous and remote monitoring of patients' vital signs, thereby improving efficiency, protecting staff, and reducing exposure. The wearable device captures body temperature, heart rate, heart rate variability, respiration rate, and SpO2, integrating with EHR systems.
2020-07
InvestmentNews
The integration challenge that led Vitals AI to shut down
Vitals AI, an advisor data reporting startup, is shutting down due to the technical and financial burdens of integrating with the fragmented advisor tech stack landscape. This article discusses the challenges faced by startups in the integration space within the financial advisory sector.
2026-04
PR Newswire
LifeLens Technologies, Inc. Announces 510(k) Clearance of Expanded Vital Sign Monitoring Indications for the LifeLens Physiological Monitor
LifeLens Technologies, Inc. received FDA 510(k) clearance for expanded vital sign monitoring indications for its Wearable Physiological Monitoring system. The clearance adds SpO2, heart rate, respiration rate, heart rate variability, skin temperature, and wellness parameters to its existing ECG acquisition clearance.
2026-07

Videos

Product demos, reviews, and walkthroughs for Vitls.

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Frequently Asked Questions

The Vitls Platform is a wireless physiologic monitoring system that utilizes the Tu00e9go sensor to continuously collect vital sign data such as heart rate, temperature, and pulse oximetry from patients. It is FDA-cleared for use in both hospital and home settings for patients aged two years and older, primarily for retrospective analysis to aid in diagnosis and treatment. The system includes cloud storage and an app for medical teams to review data remotely, aiming to improve patient care and potentially shorten hospital stays.
The Vitls Platform, with its Tu00e9go VSS sensor, monitors physiological parameters including heart rate, temperature, and pulse oximetry, and can also track respiration rate and heart rate variability. It received 510(k) clearance from the FDA in July 2020 for continuous vital sign monitoring in patients over two years old, both at home and in the hospital. However, it is not approved for use in critically ill patients, nor is it intended to replace standard vital sign monitoring or for active, real-time patient surveillance.
While specific details for Vitls Inc. were not extensively detailed in the search results, medical devices handling Protected Health Information (PHI) are generally required to adhere to HIPAA regulations. Companies like Vitale Health, which offer similar healthcare technology, implement safeguards, policies, and procedures including data encryption at rest and in transit, access controls, and regular risk assessments to ensure HIPAA/HITECH compliance. It is expected that Vitls would employ similar robust measures to protect patient data.
The Vitls Platform is designed to integrate seamlessly with existing EHR systems, allowing for automatic and immediate updates of patient data. This integration enables clinicians to convert real-time patient vital sign data into actionable intelligence, view patient data trends, and add notes within their patient dashboard. This streamlines the care process, allowing medical teams to work together and respond to changes in a patient's vitals more efficiently.
Specific pricing for Vitls Inc. was not found, but remote patient monitoring (RPM) pricing typically involves several components. These include device costs (ranging from $30-$200+ per device), software platform fees (which can be per-provider, per-patient, or an enterprise flat fee), and clinical monitoring fees. Additionally, there are often one-time implementation and training costs, which can range from $1,000 to over $10,000 depending on the practice size.
Several alternatives to Vitls exist in the remote patient monitoring market, offering various features and monitoring capabilities. Examples include VitalConnect with its VitalPatch RTM, HealthArc, Cadence, and MD Revolution, which focus on comprehensive RPM solutions and EHR integration. Other notable options include Philips Healthcare, Dexcom for continuous glucose monitoring, BioButton for symptom monitoring, and MedM, which offers a white-label RPM system with extensive device connectivity.
Yes, physicians should be aware that the Vitls Platform is not approved for use in critically ill patients. Furthermore, it is not intended to replace standard vital sign monitoring equipment or routine care, and the data collected is primarily for retrospective analysis rather than active, real-time monitoring that would necessitate immediate intervention. The device is cleared for patients aged two years and older.

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Suggest an Edit → | Last Verified: 2026-04-22 | First Added: 2026-04-22
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