FDA Clears Polarean Imaging Products for Lung Scans

The FDA has cleared three Polarean Xenoview imaging devices that work together to enable the company’s hyperpolarized gas blend contrast agent to deliver lung ventilation scans without the use of radioactive gas.

Xenoview is a drug-device combination product that works with magnetic resonance imaging (MRI) scans to measure how air moves in and out of lungs, often used to detect emphysema, or chronic obstructive pulmonary disease.

Aside from the gas blend (xenon Xe 129 hyperpolarized), the FDA cleared the company’s Xenoview 3.0T Chest Coil, which the patient must wear during the MRI to gather scan data, and Xenoview VDP image processing software that evaluates the MRI images.

The company says its product is “the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks.”