ImpediMed this week said it received expanded FDA 510(k) clearance for its Sozo bioimpedance spectroscopy device. The expanded clearance allows the Carlsbad, Calif.-based company to market the Sozo device for assessing patients that are at risk of Protein Calorie Malnutrition (PCM) and for tracking clinically relevant body composition parameters in all patients. “Many chronic diseases, […]
ImpediMed
ImpediMed shares rise on FDA nod for Sozo system
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 […]
Impedimed wins CE Mark for Sozo monitoring system
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 […]
ImpediMed, Mayo Clinic ink dev deal
Australian medtech developer ImpediMed said last week it inked a 3-year joint development deal with the Mayo Clinic. ImpediMed develops and distributes medical devices which use bioimpedance spectroscopy to provide non-invasive monitoring of fluid status in patients. ImpediMed said it will work with the Mayo Clinic to develop new body composition and fluid status monitoring tech […]
Australian ImpediMed raises $56m in private placement
Australian medtech developer ImpediMed said yesterday it closed a $56.6 million (AUD $75.1 million) private placement financing round. The company develops and distributes medical devices which use bioimpedance spectroscopy to provide non-invasive monitoring of fluid status in patients. “We would like to thank our new and existing shareholders for their ongoing support of the company. […]
