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# Polarean Imaging Complete Response Letter
- URL: https://www.fdaweb.com/polarean-imaging-complete-response-letter/
- Published: 2021-10-06T12:00:00.000Z
- Updated: 2026-09-14T17:18:07.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5150302

FDA has issued a complete response letter declining to approve in its current form a Polarean Imaging NDA for an investigational drug-device combination product using hyperpolarized xenon-129 gas to enhance MRI imaging in pulmonary medicine. The company [says](https://www.polarean-ir.com/content/news/archive/2021/061021?ref=fdaweb.com) the letter was “unexpected” and contained issues that are “mostly technical or manufacturing-related,” centering around the xenon hyperpolarizer system.

“Polarean will work to address the issues identified by FDA with a view to resubmitting the NDA and securing FDA approval as quickly as possible,” the company says.