ImpediMed Release: U.S. FDA 510(k) Clearance Issued For SOZO With L-Dex

Brisbane, Australia and Carlsbad, Calif. - ImpediMed Limited (ASX: IPD) a global provider of medical technology to non-invasively measure, monitor and manage fluid status and body composition, is pleased to announce the issuance by the U.S. FDA of a 510(k) clearance to market SOZOTM to aid in the clinical assessment of unilateral lymphoedema in the United States.

“We are delighted to receive this FDA clearance for SOZO in the U.S." said Richard Carreon, Managing Director and CEO of ImpediMed. "SOZO makes it far simpler for cancer patients to be monitored for lymphoedema via their L-Dex score and significantly streamlines the patient flow within the cancer clinic.”

“This clearance puts us ahead of schedule for our planned market launch of SOZO in the United States, and also allows us to now expedite our regulatory strategy for additional SOZO indications including fluid status monitoring for patients living with heart failure.”

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