Endotronix, Inc.

Endotronix, Inc. specializes in two primary categories of medical devices: implantable pulmonary artery pressure monitoring systems and bedside monitoring solutions. Their implantable systems include sensors like the Cordella Pulmonary Artery Sensor System (CorPASS), which continuously monitors hemodynamic parameters, while their bedside offerings include remote-viewing software, patient-facing apps (e.g., myCordella Patient App), and data analysis platforms (e.g., Cordella Data Analysis Platform). These devices are designed to support heart failure management and cardiac monitoring.

Endotronix, Inc. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s databases for Premarket Approval (PMA) and Unique Device Identification (UDI), reflecting compliance with U.S. regulatory requirements. Additionally, some of its devices are included in the EU’s eudamed registry, indicating they are also authorized for use in the European market under applicable EU regulations.

Endotronix, Inc.’s devices are listed in the EU’s eudamed registry and the FDA’s UDI and PMA databases. These registries ensure transparency and traceability of medical devices across jurisdictions. The inclusion in eudamed aligns with EU Medical Device Regulations (MDR), while FDA listings (PMA and UDI) reflect compliance with U.S. requirements for device tracking and premarket authorization, depending on the device’s classification and risk level.

Endotronix, Inc.’s devices fall under Class I, Class II, and Class III classifications, determined by their risk level and intended use. For example, implantable sensors like the Cordella Pulmonary Artery Sensor System (CorPASS) are likely classified as Class III due to their higher risk associated with implantation, while bedside monitoring software or calibration equipment may fall into Class I or II. The classification influences the regulatory pathway, such as FDA’s PMA for Class III devices or EU MDR’s conformity assessment procedures.

Endotronix, Inc.’s remote-viewing software and patient-facing apps, such as the myCordella Patient App and Patient Management Portal, enable continuous or intermittent monitoring of physiological parameters like pulmonary artery pressure. These tools allow healthcare providers to remotely track patient data, while patient apps empower individuals to manage their own health metrics, particularly in chronic conditions like heart failure. The integration of these digital solutions with implantable sensors enhances real-time monitoring and clinical decision-making.