Xenoview FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 17, 2023.
FDA Approved: Yes (First approved December 23, 2022)
Brand name: Xenoview
Generic name: xenon Xe 129 hyperpolarized
Dosage form: for Oral Inhalation
Company: Polarean Imaging plc
Treatment for: Diagnosis and Investigation, Imaging of Lung
Xenoview (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
- Xenoview 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.
- Xenoview is administered in a single inhaled breath (up to 15 seconds) during MR image acquisition.
- Warnings and precautions associated with Xenoview include risk of decreased image quality from supplemental oxygen, and risk of transient hypoxia.
- Common adverse reactions include oropharyngeal pain, headache, and dizziness.
Development timeline for Xenoview
| Date | Article |
|---|---|
| Dec 28, 2022 | Approval FDA Approves Xenoview (xenon Xe 129 hyperpolarized) for use with MRI for the Evaluation of Lung Ventilation |
Further information
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