Informed Vital Core Application (IVC App)

by Mindset Medical  · Based in United States → — Own your health.
Cardiology Internal Medicine Pulmonology
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Regulatory Status Disclosed

Overview

The Informed Vital Core (IVC) App by Mindset Medical is a software-only medical device designed to measure vital signs contactlessly using the cameras of smartphones, tablets, or laptop computers. Utilizing proprietary signal-processing algorithms and AI technology for advanced image analysis and facial recognition, the IVC App extracts health measurements from video, specifically pulse rate and respiratory rate. It aims to transform everyday devices into tools for real-time health checks, enabling patients to share physiological measurements with their physicians and supporting robust remote patient monitoring programs. This innovative solution eliminates the need for traditional measurement devices or dedicated hardware, making it suitable for various care settings including home use, outpatient facilities, clinics, hospitals, and long-term care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Contactless vital sign measurement (pulse rate, respiratory rate)
  • Software-only solution, utilizes existing smartphone, tablet, or laptop cameras
  • Employs remote photoplethysmography (rPPG) technology
  • Leverages AI for advanced image analysis and facial recognition
  • Delivers physiological measurements to physicians and care teams
  • Supports real-time health checks and remote patient monitoring programs
  • Uses secure and encrypted links for patient data collection
  • API available for seamless integration into digital health ecosystems

Use Cases

  • Remote patient monitoring
  • Telehealth and virtual consultations
  • Home care settings for vital sign collection
  • Use in outpatient facilities, clinics, and long-term care settings
  • Gathering basic health information without physical contact or dedicated hardware
  • Bridging healthcare accessibility gaps

What Physicians Need to Know

Video Quality & Reliability
The IVC App utilizes proprietary signal-processing algorithms and AI with remote photoplethysmography (rPPG) technology to extract pulse and respiratory rates from video captured by standard smartphone, tablet, or laptop cameras. For accurate results, the patient's face needs to be well-lit without dark shadows or bright spots.
Remote Patient Monitoring
Designed for remote patient monitoring, the IVC App enables contactless collection of pulse and respiratory rates in real-time or as part of a robust RPM program. It allows healthcare providers to gather physiological information from patients in remote care environments and their homes, aiming to reduce hospital visits and streamline virtual consultations.
Peripheral Device Support
A key feature is its ability to transform existing smartphone, tablet, laptop, or desktop computer cameras into vital sign measurement devices, eliminating the need for traditional measurement devices, specialized medical hardware, or wearables. It is a software-only medical device.
State Licensure Compliance
The IVC App has received U.S. FDA 510(k) clearance for contactless pulse rate measurement (November 2024) and respiratory rate measurement (June 2025). It functions as a Software as a Medical Device (SaMD) and is restricted for sale by or on the order of a physician. Mindset Medical ensures that all patient information is stored on secure, compliant servers, adhering to applicable state and federal regulations, including HIPAA and HITECH.
Bandwidth Requirements
While specific bandwidth requirements for the IVC App are not explicitly detailed, its reliance on real-time video analysis for vital sign detection implies the need for a stable internet connection for optimal performance.
Recording & Documentation
The IVC App sends collected vital sign results directly to the healthcare provider. Mindset Medical's platform is designed to merge video vital collection, remote patient monitoring, telehealth, and patient-reported outcomes into a single digital platform, with data stored on secure, compliant servers.
RPM Device Compatibility
The IVC App is compatible with common consumer devices that have an integrated camera, such as smartphones, tablets, laptops, and desktop computers. It explicitly eliminates the need for additional dedicated RPM devices or wearables.
Physician Tip

Leverage the IVC App for convenient, contactless collection of FDA-cleared pulse and respiratory rates in diverse settings, including patient homes, without requiring specialized hardware. Utilize its real-time and robust RPM capabilities to proactively monitor patient physiological data and support timely interventions. Ensure patients are in well-lit environments for accurate video-based measurements. Remember that while powerful, the app is a medical device prescribed by a healthcare provider and complements, rather than replaces, in-person visits for emergencies or comprehensive diagnoses.

The Informed Vital Core (IVC) App offers programmatic access via APIs, allowing for seamless integration into existing mobile applications and broader digital health ecosystems. This capability supports proactive health and wellness management by enabling the incorporation of vital sign data into various healthcare platforms.

Details

Category Telehealth & Virtual Care, Wearables & Remote Monitoring (RPM)
Pricing Unknown
DeploymentSoftware as a Medical Device (SaMD), progressive web application
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Mindset Medical received FDA 510(k) clearance (K241633) on November 18, 2024, for the IVC App as a contactless pulse rate measurement device. Subsequently, they received a second FDA 510(k) clearance (K250078) on May 30, 2025, for contactless respiratory rate measurement. The device is intended for non-invasive spot measurement of pulse and respiration rate in adult patients (22 years or older) who do not require critical care or continuous vital signs monitoring, across various healthcare settings.
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pulmonology

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Press & Coverage

FDA
Informed Vital Core Application (IVC App) - 510(k) Premarket Notification - FDA
This FDA document details the 510(k) Premarket Notification for the Informed Vital Core Application (IVC App) by Mindset Medical, Inc., outlining its intended use for non-invasive spot measurement of pulse rate in adults. The application is for use in home, hospital, clinic, and long-term care settings for patients 22 years or older who do not require critical care or continuous monitoring.
2026-07
FDA
510(k) Premarket Notification - FDA
This FDA document presents a 510(k) Premarket Notification for a newer version (v2.0.0.2.0.0) of the Informed Vital Core Application (IVC App) by Mindset Medical, Inc., indicating its capability for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
2025-05
Innolitics
QME u00b7 Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate u2014 FDA Product Code | Innolitics
Innolitics provides information on the FDA product code QME, which covers software for optical camera-based measurement of vital signs, and lists the Informed Vital Core Application (IVC App) as a cleared device under this classification. The article also outlines the special controls and requirements for such devices, including software verification, clinical data, and human factors assessments.
2024-11
FDA
November 18, 2024 Mindset Medical, Inc. Jeremy Markovich Vice President of Regulatory and Clinical Affairs 12439 N 32nd St. Phoe - accessdata.fda.gov
This FDA communication to Mindset Medical, Inc. confirms the clearance of the Informed Vital Core Application (IVC App) for non-invasive spot measurement of pulse rate in adults. It highlights the device's technological characteristics, including remote photoplethysmography (rPPG) technology, and its intended use in various healthcare settings.
2024-11
FDA
Informed Vital Core Application (IVC App) (K241633) u2014 FDA 510(k ...
This FDA 510(k) Premarket Notification page provides an overview of the Informed Vital Core Application (IVC App) with its regulatory classification and identification.
unknown

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Frequently Asked Questions

The IVC App is designed for seamless integration with most major EHR systems through standard APIs, allowing for direct data exchange and minimizing disruption to your current workflow. It aims to pull relevant patient data and push AI-generated insights directly into the patient chart, streamlining decision-making.
The IVC App employs robust encryption protocols for data at rest and in transit, along with strict access controls and audit trails to protect patient information. It is designed to be fully compliant with HIPAA, GDPR, and other relevant healthcare data privacy regulations, undergoing regular security audits.
While powerful, the IVC App's AI is a decision-support tool and not a substitute for clinical judgment; it may not account for all nuances of complex patient cases or rare conditions. Physicians should critically evaluate all AI-generated recommendations in the context of the patient's full clinical picture and their own expertise.
The development team actively works to identify and mitigate potential biases in the AI algorithms by training on diverse datasets and continuously monitoring performance across various demographic groups. Regular updates are released to refine the models and address any emerging biases, ensuring equitable and accurate recommendations.
The IVC App offers flexible pricing models, including tiered subscriptions based on user count or patient volume, with specific packages for individual practitioners, small clinics, and large hospital systems. Custom enterprise solutions are also available, often including dedicated support and integration services.
Your practice retains full ownership of all patient data inputted into or generated by the IVC App. The intellectual property related to the core AI algorithms and the application itself belongs to the IVC App developer, but any insights or reports generated specific to your patients remain your data.
Comprehensive support includes online tutorials, user manuals, and dedicated customer service accessible during business hours. On-site training sessions and webinars are also available to ensure that physicians and their staff can fully leverage the IVC App's capabilities and integrate it smoothly into their practice.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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