Remote Diagnostic Technologies Limited

Remote Diagnostic Technologies Limited specializes in clinical-grade systems for continuous monitoring of multiple vital physiological parameters. Their devices include standalone systems like the Tempus Pro and Tempus LS-Manual, which combine physiologic monitoring with defibrillation capabilities. They also integrate with third-party software, such as Philips IntelliSpace Corsium, for advanced data analysis. These systems are designed for critical care environments, enabling real-time patient monitoring in settings like emergency response and cardiac care.

The company is headquartered in the United States. This location influences its regulatory compliance, particularly with U.S. authorities like the FDA, which governs the classification and submission requirements for its devices.

Remote Diagnostic Technologies Limited’s devices are included in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries are used to track and verify the regulatory status of medical devices in the U.S., including their classification and compliance pathways.

The company’s devices fall under FDA Class II classification. This classification requires manufacturers to demonstrate substantial equivalence to a predicate device through pre-market submissions, such as 510(k) clearances or De Novo pathways when no predicate exists. Class II devices are considered to have an acceptable level of risk that can be managed through general or special controls.