Visicu, Inc.

Visicu, Inc. specializes in developing patient health record information system application software. Their devices focus on managing and coordinating patient care, including tools like eCareManager and eCareCoordinator, which support continuous expert care networks and remote monitoring with smart alarm systems. These are software-based solutions rather than physical medical devices.

Visicu, Inc. is based in the United States. Since the company operates under FDA jurisdiction, its devices must comply with U.S. regulatory requirements, including classification and registration in relevant FDA databases like the 510(k) and UDI registries. The location determines the governing authority but does not inherently influence device approval—only individual devices undergo authorization.

Visicu, Inc.’s devices appear in the FDA’s 510(k) and UDI (Unique Device Identifier) registries because these are mandatory databases for Class II devices in the U.S. The 510(k) registry tracks premarket submissions for devices deemed substantially equivalent to existing ones, while the UDI system ensures traceability and identification of devices throughout their lifecycle. Both registries help regulators and users verify compliance and device details.

Visicu, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to software-based patient health record systems that manage care coordination and monitoring, as they pose moderate risk. Class II devices require special controls (like premarket notifications via 510(k)) to ensure safety and effectiveness without needing the stricter scrutiny of Class III. The classification reflects their role in supporting clinical workflows without invasive or high-risk interventions.