FDAnews Device Daily Bulletin

Radi Medical Systems, a designer and manufacturer of innovative devices in interventional cardiology, has announced the 510(k) clearance of the RadiAnalyzerXpress.

The RadiAnalyzerXpress system is a lightweight, flat-panel instrument designed to be extremely easy to use. Using an on-screen guide with step-by-step instructions, instrument setup is quick and intuitive. PressureWire5 Sensor has excellent overall mechanical maneuverability, pushability and a tip design with improved shape retention, valuable during long and complex procedures.

Along with the recently released PressureWire5 Sensor, the products make up an easy-to-use system for measurement of fractional flow reserve. Radi's physiology platform is the only system on the market that provides measurement of pressure, flow and intravascular temperature using a single PressureWire5 Sensor and one instrument.