Nanovi A/S

Nanovi A/S specializes in implantable radiological image markers, which are designed to improve visibility in medical imaging. These devices are specifically intended for procedures like orthopedic or spinal surgeries where precise localization of implanted components is critical. The markers enhance radiographic identification, ensuring clearer imaging results during and after surgery.

Nanovi A/S is based in the United States. The company’s primary focus is developing implantable radiological image markers, which are used to enhance visibility in medical imaging for procedures requiring precise localization, such as orthopedic or spinal surgeries.

Nanovi A/S’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track medical devices that have undergone the necessary regulatory pathways, including premarket notifications (510(k)) and UDI compliance, which ensures traceability and identification in the healthcare system.

Nanovi A/S’s devices fall under FDA Class II classification. This classification is assigned based on the risk level of the device, with Class II devices requiring premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet safety and effectiveness standards without requiring the stricter controls of Class III.