Acarix A/S

Acarix A/S specializes in diagnostic devices focused on capturing and analyzing heart sounds. Their primary product category is phonocardiographs, such as the Acarix CADScor System and CADScor Patch. These devices use acoustic signal processing to detect and evaluate cardiac abnormalities, like aortic stenosis, by analyzing heart sounds.

Acarix A/S is headquartered in the United States. The company’s location is relevant for regulatory and compliance purposes, as it influences which regulatory bodies oversee its devices.

Acarix A/S’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures unique identification for tracking and traceability.

Acarix A/S’s devices fall under FDA Class II classification. This classification indicates moderate risk, requiring special controls in addition to general controls to ensure safety and effectiveness. Class II devices undergo premarket notification (510(k)) submissions to demonstrate equivalence to existing approved devices.