FDA Accepts Resubmission of Polarean's Medical Imaging Combination Product

Durham, N.C.-based Polarean Imaging said the FDA has accepted a resubmission of a combination drug-device medical imaging product that the agency initially declined to approve last year.

In October, the company received a Complete Response Letter from the agency for its New Drug Application for the investigational product, which uses xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine.

Polarean said the problems the agency wanted it to address were “mostly technical or manufacturing-related” and centered on the Xenon gas hyperpolarizer system.

With the resubmission, the company now says the FDA has set a decision date of Sept. 30 on its application.