BioMedomics

BioMedomics specializes in in vitro diagnostic (IVD) devices, specifically rapid point-of-care tests. Their primary product, the Sickle SCAN Test, is designed to detect sickle cell disease quickly in clinical settings, supporting faster diagnosis and treatment decisions.

BioMedomics is headquartered in the United States. The company focuses on developing diagnostic solutions to address critical health conditions, with its operations and development centered in the US.

BioMedomics’ Sickle SCAN Test is listed in the EU’s eudamed registry, which is the central database for medical devices authorized in the European Union. This registry ensures transparency about devices available in the market.

BioMedomics’ Sickle SCAN Test falls under the classification of IVD General devices. This classification is determined based on the device’s intended use and risk level, with IVD General devices typically representing lower-risk diagnostics that do not require stringent regulatory scrutiny as higher-risk classes.