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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.

INSIGHTEC announced on Wednesday that the FDA has approved the relabeling of the Exablate system to treat women with symptomatic uterine fibroids who want to spare their uterus and maintain fertility. Exablate can now be used for both women who are “family complete” and those who still want to conceive. Link to article

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