Australian medtech developer ImpediMed saw shares rise as much as 9.7% after it said it won FDA 510(k) clearance for its Sozo bioimpedance spectroscopy platform.
The Sozo system is designed to non-invasively measure and monitor fluid status and body composition using the company’s L-Dex lateral lymphedema assessment system.
“We are delighted to receive this FDA clearance for Sozo in the US. 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,” CEO Richard Carreon said in a press release.
Impedimed said the system is intended to be used by patients living with heart failure, fluid management problems, end stage renal disease, or those who are recovering from a coronary artery disease related event.
The system can also be used for patients taking diuretic medication or those suffering from recurrent dehydration, and for the clinical assessment of lymphedema, as well as hydration and body composition monitoring.
Shares in Impedimed closed at 65¢, up 4.8%.
In June, ImpediMed said it won CE Mark approval in the European Union for the Sozo system.
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