Change Healthcare Israel , Ltd.

Change Healthcare Israel, Ltd. specializes in integrated computer systems tailored for cardiac catheterization laboratories. Their portfolio includes cardiac catheterization laboratory computers, cardiac mapping systems, cardiology information systems, and ECG management solutions. These devices are designed to support clinical workflows in cardiac care settings, such as real-time monitoring, data management, and diagnostic assistance.

Change Healthcare Israel, Ltd. is based in the United States. Since the company’s devices are regulated under FDA guidelines, their products are subject to U.S. medical device classification and reporting requirements. The U.S. location also means their devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, which are key resources for tracking authorized medical devices in the U.S. market.

Change Healthcare Israel, Ltd.’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) clearance before commercial distribution, which is why their products appear in the FDA’s 510(k) database.

Change Healthcare Israel, Ltd.’s devices are included in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) database. These registries serve as official records of medical devices that have undergone the necessary regulatory processes, such as 510(k) clearance, to be legally marketed in the United States. The UDI database, in particular, provides standardized identification for tracking devices throughout their lifecycle.

The primary purpose of Change Healthcare Israel, Ltd.’s computer systems is to streamline and enhance clinical workflows in cardiac catheterization laboratories. Their solutions integrate specialized software for tasks like cardiac mapping (electrical activity visualization), hemodynamics monitoring (blood flow and pressure tracking), and ECG management (electrocardiogram data handling). These systems are designed to improve diagnostic accuracy, reduce manual errors, and support real-time decision-making for healthcare providers.