Radiaction Medical Receives FDA’s 510(k) Clearance for Its Radiation Protection System

Radiaction Medical has received the FDA’s 510(k) clearance for its Shield System for protection against radiation from the use of X-ray fluoroscopy.

The Tel Aviv, Israel-based company specializes in radiation protection during interventional cardiology and electrophysiology procedures.

The device reduces radiation by more than 90 percent, protecting all personnel in the room against the high levels of scattered radiation generated by the X-ray equipment, the company said.

Radiaction Medical now plans to launch the Shield System in the U.S. It is already available in the EU.