Hologic relaunches women's health device after FDA concerns
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Hologic's Marlborough headquarters
Hologic is relaunching an aesthetic health device four months after pulling it from the market after the U.S. Food and Drug Administration issued a warning about the overstated health benefits of a similar device.
The TempSure Vitalia device, made and marketed by Hologic subsidiary Cynosure, has returned to the market, Hologic announced in a press release last week.
The company said it has been working with the FDA over the last several months to review and update the marketing of the product to ensure consistency with guidelines.
The move to suspend the Vitalia program in August after after another Cynosure device, the MonaLisa Touch, was the subject of a letter from the FDA about some inconsistencies in its approved use and its actual use.
The FDA said the device was cleared for a variety of uses, but not for several uses listed on the device's website, including for vaginal and vulvar health, menopause symptom relief, vaginal wall healing and other vaginal uses.
The MonaLisa Touch continues to be marketed and sold, Hologic said.
“We’re pleased to reintroduce TempSure Vitalia and to continue offering MonaLisa Touch to provide clinically strong products for women’s wellness,” division president Kevin Thornal said in a statement. “Cynosure is the only medical aesthetic manufacturer to offer two different energy-based modalities for women’s wellness — radiofrequency and CO2 — and we remain committed to advancing women’s pelvic health around the globe.”
Last week’s announcement was made in conjunction with the North American launch of another device, the TempSure Surgical Technology, offering the ability to perform both surgical and non-surgical aesthetic procedures on a single device.
The technology harnesses a 300-watt and 5-MHz radiofrequency platform to enable precise incisions with minimal lateral damage to surrounding tissues to allow for quicker recovery and better healing in patients.
The device can be used in a variety of specialty fields, including plastic surgery, dermatology, gynecology and ophthalmology, the company said.
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