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DR System Receives Landmark Department of Defense Cybersecurity Certification

The RadPRO SOLTUS 100M Mobile Digital X-Ray System from Virtual Imaging, Inc, a Canon company, has received cybersecurity certification for the Risk Management Framework (RMF) program of the United States Department of Defense. Canon USA recently announced that the Department of Defense purchased more than 100 units of the RadPRO SOLTUS 100M system from Virtual Imaging for field use. The RadPRO SOLTUS 100M System is the first medical device to obtain this certification as part of the military’s portable DR system project.

“This certification is the culmination of a successful collaboration among Virtual Imaging, Canon USA, Canon Inc, and the Department of Defense,” says Tsuneo Imai, vice president and general manager of the Healthcare Solutions Division of the Business Imaging Solutions Group at Canon USA, Inc, and president of Virtual Imaging, Inc. “As the United States government has a strict framework in place regarding the cybersecurity of its health care devices, Canon worked closely with all parties for a year and a half to ensure that the SOLTUS 100M System met the necessary criteria of the certification process. By achieving this status, Virtual Imaging has taken steps to help shield military users of the SOLTUS 100M System from potentially catastrophic data breaches.”

The Department of Defense’s RMF program sets the security standards across federal government departments and agencies, helping to improve information security and reinforce risk management initiatives to meet federal regulations and directives. To meet these standards, Virtual Imaging applied custom changes to Canon’s DR software, CXDI Control Software NE, which is included in the SOLTUS 100M System. By making these changes, the software’s security features have been bolstered to meet the strict criteria of the US government. In order to confirm the enhanced security of the device, the RadPRO SOLTUS 100M System underwent rigorous cybersecurity testing at Army facilities. 

“Not enough can be said about how important it is to protect the private health information of our patients,” says Diego Gomez-Morale, biomedical equipment specialist for the US Army Medical Materiel Agency, a subordinate organization of the US Army Medical Research and Materiel Command. “This was truly an ‘all hands on’ approach, with Virtual Imaging, Canon, and the Department of Defense all successfully working together to help the RadPRO units become the first medical device used by the Army to receive its Authority to Operate under the new RMF. This certification has given us comfort in knowing that the security features of the portable digital radiography system will help prevent our patients’ sensitive data from falling into the wrong hands.”

— Source: Canon USA, Inc