Australian medtech developer ImpediMed said today it won CE Mark approval in the European Union 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.
With the clearance, the Sozo platform is indicated for use as a bioimpedance spectroscopy platform for use in hospitals, clinics and in patient’s homes under a clinician’s direction, the company said.
“Obtaining CE Mark for multiple indications for the Sozo platform is a pivotal regulatory and commercial milestone for ImpediMed, enabling us to now make Sozo commercially available to physicians and patients throughout Europe and Australia. The Sozo platform is a sophisticated connected medical device that offers significant advantages over our previous BIS products. Testing time has been reduced to mere seconds versus tens of minutes, testing no longer requires an exam room, gel backed electrodes, or the need for a highly-trained clinician to administer the test. Data can be integrated straight into a patient’s electronic health records and our cloud based system allows us to analysis data streams in real-time. We are already seeing this seamless integration work first hand from several of our clinical sites,” CEO & managing director 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.
Last March, ImpediMed said it closed a $56.6 million (AUD $75.1 million) private placement financing round to support its devices which use bioimpedance spectroscopy to provide non-invasive monitoring of fluid status in patients.