FDA-Cleared ACM System

Introduction of an FDA-Cleared Ambulatory Cardiac Monitoring System developed by ITR

ITR (https://itrvn.com/), a technology design and engineering company, has developed the Ambulatory Cardiac Monitoring system to innovate the accuracy and efficiency of diagnosing heart disease. This state-of-the-art system consists of a wearable medical device, mobile app, web portal, cloud infrastructure, and proprietary AI algorithms.

ITR’s Ambulatory Cardiac Monitoring (ACM) system is FDA-Cleared and satisfies all regulatory and standard requirements for ambulatory cardiac devices. With its advanced features and innovative technology, the system offers unparalleled accuracy, efficiency, and convenience, helping to improve patient outcomes and reduce healthcare costs.

Business Needs and Technical Challenges

The healthcare industry faces significant challenges in accurately diagnosing heart disease, which is a leading cause of mortality worldwide. Existing cardiac monitoring solutions often require patients to wear bulky devices and visit clinics, which can be inconvenient and expensive. In addition, many existing systems lack the accuracy and efficiency needed to diagnose cardiac abnormalities in a timely manner.

The ACM system from ITR addresses these challenges by offering a wearable medical device that continuously monitors ECG (Electrocardiogram) data and transfers it to a cloud infrastructure for analysis. The system’s advanced AI algorithms can detect cardiac abnormalities with unprecedented accuracy and efficiency, while the mobile app and web portal provide patients and healthcare providers with convenient access to the ECG data and insightful reports. By addressing these technical challenges and business needs, the system has the potential to revolutionize cardiac monitoring and improve patient outcomes.

ITR’s Technology for the Ambulatory Cardiac Monitoring System

The ACM system developed by ITR is a comprehensive healthcare solution that provides continuous monitoring of ECG data to help diagnose heart disease. The system comprises several key elements, including:

• The Ambulatory Cardiac Monitoring Device is a small and lightweight wearable medical device designed to continuously monitor ECG data. It features wireless connectivity options, including Bluetooth Low Energy (5.2) and LTE CAT M1/NB-IoT, and has 32GB of onboard storage. The device is equipped with the ultra-low power ECG AFE solution MAX30001 from Analog Devices, which ensures accurate and reliable ECG measurements while minimizing power consumption. The device can operate continuously for up to 7 days on a single charge, making it easy for patients to wear the device throughout their daily activities. The device is easy to use and features a simple and intuitive interface that allows patients to start monitoring their heart health with just a few taps on their smartphone.
• The Ambulatory Cardiac Cloud infrastructure is built on top of AWS cloud services, providing a scalable and secure platform for storing and processing the ECG data collected from the Ambulatory Cardiac Monitoring Devices. The platform is designed to satisfy all security requirements related to medical records and other personal health information in the US including HIPAA (Federal Health Insurance Portability and Accountability) and HITECH (Health Information Technology for Economic and Clinical Health Act). In addition, it is also compliant with the EU’s GDPR. The ECG data is processed using ITR’s proprietary AI algorithms, which are trained on large datasets of ECG data to detect cardiac abnormalities with unprecedented accuracy and efficiency. These algorithms leverage machine learning and deep learning techniques to analyze the ECG data and generate insights that can help healthcare providers diagnose and treat heart disease. The platform also provides real-time monitoring and alerts to healthcare providers when abnormalities are detected, enabling them to take timely and informed decisions.
• The Ambulatory Cardiac Mobile Apps (supporting both iOS and Android) and Ambulatory Cardiac Web Portal provide convenient access to the ECG data and insightful reports, enabling patients and healthcare providers to monitor and diagnose heart disease. In addition, the web portal also supports the following functionalities:
• Devices management
• Healthcare Professional management
• Patient Management
• ECG Data Studies and Reports management.

Overall, the ACM system is designed to meet all regulatory and standard requirements for ambulatory cardiac systems. More importantly, the system is FDA cleared and is being deployed in the US’s healthcare environment. With its advanced features and innovative technology, the system offers unparalleled accuracy, efficiency, and convenience, helping to improve patient outcomes and reduce healthcare costs.

The achievements of ITR’s Ambulatory Cardiac Monitoring System

The ACM System developed by ITR can bring so many benefits to the US healthcare market.

• Firstly, it can help doctors and clinicians to diagnose cardiac disease at an early stage, thereby improving patient outcomes and reducing the need for expensive and invasive procedures. The system also provides a convenient and non-invasive way for patients to monitor their heart health, allowing for early detection of any abnormalities.
• Additionally, the cloud-based infrastructure of the system ensures that ECG data is securely stored and processed, satisfying all necessary security requirements for medical data in the US. The use of AI algorithms can help reduce the workload of doctors and clinicians, as they can automate many of the tasks involved in analyzing ECG data.
• Furthermore, the ACM System has the potential to reduce healthcare costs, as early detection and prevention of cardiac disease can prevent the need for expensive and complex procedures in the future. Finally, the system can improve the overall quality of care for patients with cardiac disease, leading to better outcomes and a higher standard of living for patients.