Newly approved radiation protection system said to reduce exposure by 90%
The U.S. Food and Drug Administration’s latest radiological clearance should come as welcome news to radiologists and cardiologists who perform interventional procedures.
Radiaction Medical, based in Tel Aviv, Israel, announced the FDA 510(k) clearance for its Radiation Shielding System on October 27. The novel robotic system is compatible with the Siemens Artis family of fluoroscopy C-Arm machines, both new and legacy.
The shielding system offers head-to-toe protection from scatter radiation and prior research has found that its use can reduce radiation exposure to an entire interventional lab by more than 90%, with higher reductions for the head and upper body. It does this by overcoming limitations of other shielding systems that have gaps in protection. It can be activated by a simple button touch.
“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,” Radiaction’s CEO Jonathan Yifat said in a release. “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.”
Radiaction specializes in radiation protection, particularly in the realm of interventional procedures. This latest clearance builds upon some of their prior clearance with Toshiba Infinix-I systems. The company recently opened its U.S. headquarters and training center in Fort Lauderdale, Florida.
A video demonstration of the new radiation protection system can be viewed on Radiaction’s website.
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