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FDA OK’S CHANGES FOR INSIGHTEC’S EXABLATE

MR-guided focused ultrasound (MRgFUS) developer INSIGHTEC has received U.S. Food and Drug Administration (FDA) clearance for a new version of its Exablate device and a change in labeling.

The new version of system is cleared for the treatment of symptomatic uterine fibroids, and with the updated labeling, fibroid tissue ablation can now be considered for patients who wish to retain fertility, the company said.

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FIRST MRI-GUIDED ULTRASOUND DEVICE TO TREAT ESSENTIAL TREMOR GETS FDA APPROVAL

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