October 28, 2022 — Radiaction Medical, Ltd, a medical device innovator dedicated to providing healthcare practitioners and personnel with effective radiation protection during interventional procedures, announced today that it has received supplemental 510(k) clearance from the FDA. Food and Drug Administration (FDA) for its radiation protection system that enables compatibility with the Siemens Artis family of C-Arm fluoroscopy machines. The Shield system functions as an accessory to new and legacy C-arm models. From its market debut in the spring of 2022, the radiation shielding system stands alone as the only fully automated and integrated head-to-toe shielding device that blocks the scattering of radiation at the source. Building on its previous authorization with Toshiba Infinix-I systems, this latest authorization allows the Shield System to be used in a greater number of interventional cardiology and electrophysiology laboratories in the United States, expanding the availability of Radiaction’s potentially life-saving radiation shield to now more physicians and staff.
Fluoroscopy-guided procedures have become the leading source of occupational exposure to ionizing radiation for healthcare providers. Currently available radiation protection solutions have limitations – they leave gaps in full-body coverage, provide reduced protection for personnel, and create obstacles that can limit access to the patient. Radiation technology blocks the threat of radiation exposure and eliminates these limitations. Clinical studies have shown that the Shield system can reduce radiation scatter throughout the interventional laboratory by over 90%1, with even greater reductions in the heads and upper body of attending physicians.
“The responses to our Shield System technology and capabilities have been extremely encouraging. There is growing awareness of the negative consequences of radiation exposure to interventional laboratory personnel, but until now there has been no meaningful, comprehensive way to address the problem,” said Jonathan Yiffat, CEO of Radiaction. “We are now in a historic position and uniquely poised to bring a truly novel, integrated and automated solution to market and directly into the hands of dedicated healthcare providers at all levels delivering first-class patient care.”
As Radiaction grows to take advantage of new opportunities in interventional cardiology and electrophysiology created by FDA clearance, the company is building its US footprint, recently opening its headquarters and training center in Fort Lauderdale, Florida. The fully operational demonstration, training and visiting center will host and train doctors and hospital staff.
To expand the company’s market reach, Radiaction recently appointed Amanda Bloom as vice president of marketing. Her mission is to sharply focus on expanding Radiaction’s market awareness and product manufacturing capabilities. She also plans to develop education, support and advocacy tools to ensure the company’s growing customer base is fully supported as they understand and embrace this exciting new technology.
The additional FDA 510(k) clearance along with Radiaction’s new staff and facilities are milestone events marking a turning point for the rapidly growing organization. Now, with the Radiation Shielding System, physicians can deploy a radiation shielding device with the push of a button, fully protecting themselves and their staff.
For more information: www.radiactionmedical.com
Laish-Farash A, et al. EuroIntervention 2022; 18: 262-266.