Radiaction Medical Ltd. Receives FDA Clearance for its Innovative Radiation Protection System and Secures $10M for US Launch and Commercialization
Radiaction Medical Ltd. (“Radiaction”), an innovative medical device company focused on radiation protection in the interventional cardiology and electrophysiology sectors, announced FDA 510(K) clearance for the marketing of its Shield System in the US.
In addition, the company has completed a $10 million round of financing led by current investors, InnovaHealth Partners. Proceeds will be used to launch Radiaction’s Shield System in the US and to further commercialize in Europe.
Individuals working in catheterization laboratories (“cath labs”) are exposed to high levels of scattered radiation generated from the use of X-ray fluoroscopy. The medical teams wear heavy lead aprons for protection, but their heads, arms and legs are unprotected, leading to an increase in risk for brain tumors, cognitive degradation and other radiation-related illnesses. In addition, the heavy lead aprons can cause severe orthopedic injuries. A significant part of the radiation is scattered throughout the cath lab by its interaction with the patient’s body and X-ray table. Mounted directly on the C-arm, Radiaction’s Shield System blocks and captures the scattered radiation at the source. Clinical studies demonstrate that the device reduces radiation in the entire cath lab by over 90%, with even higher reduction rates to the head and upper body of all personnel in the room.
Jonathan Yifat, Radiaction’s CEO, said, “We are very pleased with the FDA clearance of our device and look forward to protecting the physicians and medical personnel performing interventional procedures in the US. This financing will drive our commercialization in the US and Europe, and allow us to build our team and market presence. We are excited to take this next step with our long-time partner, InnovaHealth Partners, who has tremendous experience backing the fast commercial growth of technology companies.”