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FDA clears fat-reduction system

Article-FDA clears fat-reduction system

Washington — The Food and Drug Administration has cleared Liposonix, a system for noninvasive waist-circumference reduction by Medicis, for U.S. sales, reports.

The system, which uses high-intensity focused ultrasound technology to permanently destroy targeted fat just beneath the skin, already is marketed in Canada, Europe and Japan. As announced in February, Medicis is exploring alternatives for its Liposonix business, including selling it. Medicis officials said they are not planning to launch the Liposonix system in the United States, anticipating instead that plans for a U.S. launch will be announced if and when an acquisition occurs.

The Liposonix system was evaluated in a multicenter, randomized, sham-controlled, single-blind study, and safety of treatment was assessed through 24 weeks post-treatment. Adverse events included procedural and postprocedural pain, bruising and swelling, but these were mostly mild and short-lived, and resolved without incident.

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