Radiation Shielding System Gets Expanded FDA 510(k) Clearance

The Radiation Shielding System, an emerging system that reduces exposure to ionizing radiation associated with fluoroscopy C-arm devices, has garnered an expanded 510(k) clearance from the Food and Drug Administration (FDA), according to the manufacturer Radiaction Medical.

The company said the expanded FDA clearance covers compatibility of the Radiation Shielding System with Siemens Artis fluoroscopy C-arm systems. The system is also compatible with Toshiba Infinix-I devices (Canon Medical).

Radiaction Medical noted the Radiation Shielding System, which received initial FDA 510(k) clearance in March 2022, encapsulates the imaging beam of fluoroscopy C-arm systems, blocking scattered radiation at its source. One study showed that the Radiation Shielding System reduces radiation scatter by more than 90 percent during interventional procedures.¹

“The reactions to our Shield System technology and capabilities have been extremely encouraging. Awareness has been growing about the negative implications of staff radiation exposure in interventional labs, but until now, there was no meaningful, comprehensive way to address the problem,” noted Jonathan Yifat, the CEO of Radiaction Medical.

Reference

1. Laish-Farkash A, Harari E, Finkelstein A, et al. A novel robotic radiation shielding device for interventional cardiology procedures. EuroIntervention. 2022;18:262-266.