China-based Rainmed Medical Limited has announced that it has received market approval from Australia’s Therapeutic Goods Administration (TGA) for its in-house developed coronary angiography-based fractional flow reserve system (caFFR System). The approval marks another significant milestone for the company in expanding its global footprint.
Product Overview and Benefits
The caFFR System is designed for the accurate diagnosis of coronary artery disease (CAD) and the assessment of the severity of myocardial ischemia caused by coronary stenosis, a related cause of CAD. The product aims to replace the use of a pressure guide wire, thereby significantly reducing technical error and operation time. This advancement enhances the accuracy and efficiency of physiological assessments in patients with coronary artery disease.
Global Approvals and Market Expansion
The approval from the TGA follows previous regulatory approvals obtained by Rainmed Medical in the European Union, China, Serbia, and South Africa. This global expansion underscores the company’s commitment to providing innovative solutions for the diagnosis and management of cardiovascular diseases.-Fineline Info & Tech
