HEALTHY.IO LTD

Healthy.IO Ltd specialises in two primary categories of medical devices: wound management software with image-analysis capabilities, which helps clinicians assess and document wounds remotely, and self-testing data presentation software for in vitro diagnostics (IVD). These include applications like kidney function tests and urine analysis systems, where users generate test results for clinician review.

Healthy.IO Ltd is based in the United States. The company’s devices are authorised for use in the US, where they are regulated under FDA pathways such as 510(k) clearances and the Unique Device Identifier (UDI) system. These pathways apply to both Class I and Class II devices in their portfolio.

Healthy.IO Ltd’s devices are listed in the FDA’s 510(k) clearance registry and the Unique Device Identifier (UDI) system. These registries track authorised medical devices in the US, ensuring transparency and compliance with regulatory requirements.

Healthy.IO Ltd’s devices fall into two regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.

Healthy.IO Ltd’s wound management software focuses on image-analysis tools that assist clinicians in remotely evaluating and documenting wound conditions, often for home or outpatient use. In contrast, their IVD-related applications, such as kidney function tests and urine analysis systems, are designed for self-testing by users, with results intended for clinician interpretation. The distinction lies in their purpose: one aids in wound assessment, while the other supports diagnostic testing.