The Ministry of Food and Drug Safety (MFDS) in South Korea has granted approval for US-based medical device firm ViewRay to sell its magnetic resonance imaging (MRI) guided radiation therapy system in the country.
MFDS was formerly known as the Korean Food and Drug Administration (KFDA).
The first treatment started this month, less than four weeks after the system was equipped at Seoul National University Hospital (SNUH).
SNUH professor Hong-Gyun Wu selected the ViewRay system to treat a single liver metastasis patient with stereotactic body radiation therapy (SBRT).
Dr Wu said: "We are extremely pleased that our clinical MRI guided radiotherapy programme is underway, with the completion of our first patient treatment.
"The ability to visualise the tumour and surrounding soft tissues throughout treatment was unlike anything we’ve experienced before and will significantly enhance our ability to deliver the best care to the patients we serve."
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Through real-time MRI imaging during treatment, the system offers the accuracy needed to deliver the required high doses to the target and minimise damage to surrounding healthy tissue.
ViewRay president Chris Raanes said: "Receipt of Korean regulatory approval and the completion of the first international patient treatment are exciting milestones for us as we work to bring the benefits of MRI guided radiation therapy to patients around the world.
"We are particularly pleased with how quickly and easily the system went from installation to first patient treatment."
Opened in March 2011, the Cancer Hospital at SNUH provides medical service to cancer patients at its 15 cancer speciality centres and nine multidisciplinary cancer treatment centres.
In addition to ViewRay, the MRIdian system is a registered trademark of the company that provides continuous soft-tissue imaging during treatment, using MRI guided radiation therapy.
This helps clinicians to see where the actual radiation dose is being delivered and adapt to changes in the patient’s anatomy.