FDA rejects drug/device combo

Oct. 6, 2021

North Carolina-based Polarean Imaging announced this week that the FDA has kicked back its application for a new product aimed at improving medical imaging.

The clinical-stage company said it had submitted a new drug application for a drug-device combo using hyper-polarized xenon gas to enhance pulmonary MRI scans. In its complete response letter (CRL), the FDA said that the company would have to remedy a number of technical and manufacturing issues related to its product, the Xenon hyperpolarizer system. The company, however, did not disclose the specific issues raised by the agency.

Polarean’s CEO said the company was “obviously disappointed” by the CRL but that the fixes needed to satisfy the agency are “attainable.”

News of the CRL tanked the company’s shares by nearly 60% Wednesday morning.