The AURA 10 specimen imager developed by Belgian medical technology firm XEOS has been approved from the FDA. This AURA 10 aims to help improve the outcomes of surgical procedures across America. United States.
The AURA 10 specimen imager is the only PET-CT that is designed specifically for the operating room (OR) approved from FDA. Food and Drug Administration (FDA). The device provides doctors and specialists in imaging with an degree of accuracy that harnesses the ability to detect PET imaging, with submillimeter resolution spatial resolution. This AURA 10-mobile scanner makes sure that high-quality images of the specimen are taken in the OR just 10 minutes after surgery and removing the need to transport specimens to pathology or radiology departments after the surgery. This breakthrough promises to revolutionize the intraoperative diagnostics landscape providing real-time information that will make a improvements in the patient’s care.
Considered to be among the top challenging regulatory processes in the world this approval process is managed by FDA to ensure that medical products are secure and efficient in the United States. It is a proof that a business is able to provide quality and value-added solutions, that are based on adhering to the strict requirements of the law which require an in-depth examination of both technical as well as clinical information. The granting of FDA approval indicates that the device is built on an established scientific foundation and proves that it is genuinely beneficial to patients’ well-being and health.
Roel Van Holen, CEO of XEOS Roel Van Holen, CEO of the XEOS company, stated: “The FDA approval is an incredible achievement that demonstrates our determination to push the field of healthcare forward with innovative imaging solutions. It is the AURA 10, a game-changing device that grew out of 10 years of in research and development has been approved to be sold on the US market after a successful introduction in Europe in 2022.”
Traditional PET/CT images play a crucial part in the diagnosis and subsequent treatment for a range of medical illnesses. But, there is a rising challenge in healthcare systems around the world, as an increase in complex patients put pressure on the efficiency of intraoperative care, which not only affects the operating room as well as other departments, like pathology and radiology. A rapid confirmation of the excised specimens during surgery is essential. It is essential that the AURA 10 helps surgeons take an informed decision at the time through the use that molecular imaging can provide. The pilot studies conducted on different types of cancer (including prostate cancer, breast cancer and cancer of the neck and head region, and a myriad of other types) demonstrate promising results when it comes to diagnosing precision.
Vincent Keereman, CMO at XEOS Vincent Keereman, XEOS’ CMO, stated: “We are actively working with healthcare facilities throughout the United States to introduce the AURA 10 into their workflows in the hope of improving the patient experience, confidence in the clinical process, and the efficiency of surgery. The operating room is faced with immense challenges due to complexity and volume of patients. Our goal is to reduce the pressures. The cutting-edge technology of AURA 10 assists surgeons in getting the best image for their needs and analyzing it in the correct manner. This could significantly reduce the amount of time needed to perform a surgical evaluation and eliminate the need for further procedures. Beyond its efficiency and efficiency, the AURA 10 also has the possibility of providing the peace of mind for patients by ensuring that the procedure is completed to its intended. It ensures that patients will be treated correctly.”