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Medical Devices / Regulatory Affairs

FDA Issues Updates on Overheating Problems in MR-Guided Lasers

Nov. 13, 2018
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The FDA announced that Monteris is releasing a new version of its NeuroBlate probe to address a problem with overheating of its magnetic resonance-guided laser thermal therapy device. The new probe is equipped with a non-metallic fiber optic sensor.

In a Nov. 8 update, the FDA recommended that users of the probe — a component of the NeuroBlate system that is used in the removal of brain lesions — weigh the risk and benefits of using it on a patient-to-patient basis until the new model is available and consider alternative treatments.

The agency also summarized recommendations from Monteris on the NeuroBlate system and from Medtronic on its Visualase thermal therapy system.

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