FDA clears Gynesonics’ sonography-guided transcervical fibroid ablation system

Sonata system in use. (Image courtesy of Gynesonics)

Women’s healthcare company Gynesonics (Redwood City, Calif.) said it has received 510(k) clearance from the FDA to market its Sonata sonography-guided transcervical fibroid ablation system.

Sonata combines a breakthrough integrated technology — the first intrauterine ultrasound system — with a proprietary radiofrequency ablation device, providing a transcervical, incision-free, uterus-preserving treatment for uterine fibroids, the company said in a statement.

With an estimated volume of more than 1 million annual global fibroid procedures, Gynesonics projects a $3 billion-$4 billion global market opportunity for Sonata, including a market opportunity of more than $1 billion in the U.S. alone.

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