Israeli medical radiation equipment manufacturer Radiaction Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its Radiation Shielding System.
The Radiation Shielding System is designed to function as an accessory to new and legacy C-arm models and is compatible with the Siemens’ Artis line of fluoroscopy C-Arm devices.
Also, it is the only fully automated and integrated, head-to-toe shielding device that blocks radiation scatter at its source, said the company.
With the FDA approval in place, the Shield System can be accessed by a larger number of physicians and staff at interventional cardiology and electrophysiology labs across the US.
Radiaction CEO Jonathan Yifat said: “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.
“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.”
According to the company, fluoroscopy-guided procedures have become a leading source of occupational ionising radiation exposure for healthcare providers.
However, the currently available radiation protection solutions have limitations, including reduced protection to staff, and obstructions that can limit access to the patient.
Radiaction claimed that its Shield System technology eliminates the threat of radiation exposure, along with its limitations.
The system is said to have been shown to reduce over 90% radiation scatter to the entire interventional lab, and further reductions to the heads and upper bodies of the physicians, in clinical studies.
Furthermore, Radiaction is expanding its US footprint through its recently opened US Headquarters and Training Center in Fort Lauderdale, Florida.
Also, the company has appointed Amanda Bloom as marketing vice president to focus on expanding its market awareness and developing education, support, and advocacy tools.
