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IMRIS Obtains Korean FDA Approval For IMRISneuro Systems

IMRIS has gained regulatory approval from the Korean FDA permitting the company to begin marketing of its 1.5 Tesla and 3.0 Tesla IMRISneuro systems in South Korea.

The company claims that IMRISneuro provides surgical imaging solution with a high degree of safety for both the patient and the surgical environment. The system does not require the patient to be transported for magnetic resonance scanning, so the optimum position for neurosurgery is never compromised.

Clinical workflow and surgical access to the patient is not impacted and the

magnet is removed completely from the operating room, when scanning is complete. IMRISneuro provides neurosurgeons with timely images during surgery from which they are able to make better decisions for their patients, said the company.

David Graves, CEO of IMRIS, said: “South Korea is the growing medical equipment markets in the world. We continue to expand our global presence, and receiving regulatory approval in South Korea is another important step in our continuing efforts to increase penetration of global markets with our products.”