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FDA approves sweat treatment

Article

Miramar Labs has issued a statement saying it has received Food and Drug Administration 510(k) clearance for the miraDry System, a treatment for primary axillary hyperhidrosis.

Sunnyvale, Calif. - Miramar Labs, based here, has issued a statement saying it has received Food and Drug Administration 510(k) clearance for the miraDry System, a treatment for primary axillary hyperhidrosis.

According to Miramar, the miraDry System delivers electromagnetic energy subcutaneously to underarm sweat glands, resulting in thermolysis of the sweat glands. The procedure takes about an hour per office visit and is typically conducted in two visits. The procedure requires local anesthetic and little or no downtime, the company says.

A randomized, blinded clinical study that involved 120 participants at seven trial sites resulted in efficacy and safety data that were virtually stable from three months out to 12 months, according to the statement.

The company says the miraDry System will be available later this year.

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