With the expanded indication, the SculpSure is now cleared for treatments of the back and inner and outer thighs, the Marlborough, Mass.-based company said. The device is already cleared for treatment of the abdomen and flanks.
The SculpSure is designed to permanently eliminate fat cells using a selective wavelength laser that targets fat cells under the skin, Hologic said. The laser raises the temperature of body fat in order to disrupt and destroy the cells which are naturally eliminated over time and do not return.
“The approval of SculpSure to treat back fat and the inner and outer thighs is a direct response to the growing needs of our consumers, who are looking to achieve a slimmer appearance and enhance the body they work hard to maintain. Cynosure is a leader in medical aesthetics and pioneer in light-based fat reduction, and we expect the addition of three known body problem areas to SculpSure’s already advanced, versatile treatment to further drive demand and pave the way for future innovations,” Cynosure divison prez Michael Davin said in a press release.
Last week, Hologic said it won new FDA labeling for its Genius 3D mammography system, touting it as the only such device approved as superior to 2D mammography in women with dense breasts.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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