Hologic wins expanded FDA nod for Cynosure SculpSure

Hologic (NSDQ:HOLX) said today it won expanded FDA 510(k) clearance for its subsidiary Cynosure’s SculpSure non-invasive body contouring laser, now cleared to treat the submental area.

The new treatment indication expands the total for the company to 6, as the device is already cleared to treat the abdomen, flanks, back, inner and outer thighs, the Marlborough, Mass.-based company said.

“Most patients in the 57-person clinical trial received two brief treatments six weeks apart. The short treatment time, 100% satisfaction rate, and dramatic contour reductions typically seen in the study patients give SculpSure the edge as the treatment of choice for the submental area,” SculpSure clinical trial principal investigator Dr. Lawrence Bass said in a press release.

The SculpSure device is a body contouring laser device designed to disrupt and destroy fat cells under the skin through treatments lasting approximately 25 minutes, the company said.

“We are encouraged that our chin treatment was proven effective on patients with a body mass index up to 43, while our competition in the non-invasive arena is only FDA-cleared to treat patients with a BMI up to 30. We are excited to provide our customers with a competitive advantage that can further widen their patient communities,”  Cynosure division prez Kevin Thornal said in a prepared statement.

In late August, Hologic said it launched its Brevera breast biopsy system designed for real-time breast biopsy and verification.

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