FDA Clears Radiation Shield System From Radiaction Medical

Radiaction Medical Ltd. has received additional U.S. Food and Drug Administration (FDA) 510(k) clearance for its Radiation Shielding System, enabling compatibility with the Siemens Artis family of fluoroscopy C-Arm machines.

The Shield System functions as an accessory to new and legacy C-arm models. Since its market debut this past spring, the Radiaction Shield System stands alone as the only fully automated and integrated, head-to-toe shielding device that blocks radiation scatter at its source, according to the company. Building upon its previous clearance with Toshiba Infinix-I systems, this latest authorization permits the Shield System to be used in a greater number of U.S. interventional cardiology and electrophysiology labs, expanding the availability of Radiaction’s potentially life-saving radiation shield to more physicians and staff.

“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,” CEO Jonathan Yifat said. “We are now in a historic position and uniquely poised to drive a truly novel, integrated, and automated solution to market, and directly into the hands of the dedicated healthcare providers at all levels delivering top-tier patient care.”
 
Fluoroscopy-guided procedures have become a leading source of occupational ionizing radiation exposure for healthcare providers. Currently available radiation protection solutions have limitations—leaving gaps in full body coverage, providing reduced protection to staff, and creating obstructions that can limit access to the patient. Radiaction’s technology blocks the threat of radiation exposure and eliminates these limitations. Clinical studies have shown that the Shield System can reduce radiation scatter to the entire interventional lab by over 90%,¹ with even higher reductions to the heads and upper bodies of the treating physicians.
 
As Radiaction grows to take advantage of new opportunities in interventional cardiology and electrophysiology created by the FDA clearance, the company is building out its U.S. footprint, recently opening its U.S. headquarters and training center in Fort Lauderdale, Fla. The fully operational demonstration, training, and visitation center will host and educate physicians and hospital staff.
 
To extend the company’s market reach, Radiaction recently appointed Amanda Bloom as vice president of Marketing. Her mission is to focus sharply on expanding Radiaction’s market awareness and product pipeline capabilities. She also plans to develop education, support, and advocacy tools to ensure that the company’s growing customer base is fully supported as they understand and adopt this compelling new technology.
 
Based in Tel Aviv, Israel, Radiaction offers the Shield System to create a radiation-safe environment for all healthcare team members, boosting X-ray protection with full-body shielding to all staff during fluoroscopy-guided procedures. Placed on the fluoroscope’s C-arm, the Shield System encapsulates the imaging beam and blocks scattered radiation at its source, without increasing radiation to the patient or affecting imaging. This represents a paradigm shift in medical staff radiation protection. Installations target the interventional cardiology and electrophysiology markets, where the highest radiation exposures occur.
 
Radiaction was founded by Amir Belson, M.D. and its lead investor is InnovaHealth Partners LP.
 
Reference
¹ Laish-Farkash A, et al. EuroIntervention 2022;18:262-266.