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The company says the 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.”
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.
The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the drug-device combination a priority review.
The De Novo pathway is an option for applicants with novel medical devices which are considered reasonably safe and effective under certain controls, but have no legally marketed predicate device.