Xeos receives FDA clearance for AURA 10 specimen imager

The AURA 10 specimen imager by Belgian medtech firm XEOS has been cleared by the FDA. The AURA 10 aims to help enhance surgical outcomes in the United States. 

The AURA 10 specimen imager is the first-ever PET-CT for the operating room (OR) cleared by the Food and Drug Administration (FDA). This device presents surgeons and imaging specialists with a level of precision that harnesses the sensitivity of PET imaging with submillimeter spatial resolution. The AURA 10 mobile scanner ensures that high-quality specimen images are captured in the OR, a mere 10 minutes after excision, effectively eliminating the need for specimen transport to the radiology or pathology departments during surgery. This advancement promises to transform the landscape of intraoperative diagnostics, offering real-time insights that can make all the difference in patient care.

Recognised as one of the most demanding regulatory pathways globally, the approval process is overseen by the FDA to ensure medical devices are safe and effective when introduced into the United States. It demonstrates that a company can deliver compliant and value-added solutions, based on adherence to stringent legislative requirements, which involve a detailed analysis of both technical and clinical data. Receiving FDA approval means that a device has a sound scientific foundation and testifies to the fact that it genuinely enhances patient health and well-being. 

Roel Van Holen, CEO of XEOS, said: “The FDA approval is a momentous achievement that underscores our commitment to propel healthcare forward through cutting-edge imaging solutions. The AURA 10, a game-changing device born from a decade of molecular imaging technology research and development, is now authorised for the US market, following its successful introduction in Europe in 2022."

Conventional PET/CT imaging plays a pivotal role in diagnosis and follow-up for a variety of medical conditions. However, there is a growing challenge in healthcare systems worldwide, as an increasing volume of complex patients puts pressure on intraoperative efficiency, which impacts the operating room but also other departments, such as radiology and pathology. Rapid verification of excised specimens during surgery is therefore of the utmost importance. The AURA 10 helps surgeons take informed decisions right on the spot by harnessing the power of molecular imaging. Pilot studies in various cancer types (including breast cancer, prostate cancer, cancer of the head and neck region and many others) show promising results in terms of diagnostic accuracy.  

Vincent Keereman, CMO at XEOS, added: “We are actively working with healthcare institutions across the United States to introduce the AURA 10 into their workflows, with the aim of improving patient care, clinical confidence, and surgical efficiency. The operating room faces enormous challenges in terms of patient volume and complexity. We aim to alleviate these pressures. The innovative technology of the AURA 10 assists surgeons in acquiring an ideal image for their purposes and analysing it immediately in the right way. This may significantly reduce the time required for surgical assessment and prevent the need for additional procedures. Beyond its precision and time-saving capabilities, the AURA 10 also has the potential to extend peace of mind to patients by helping to ensure that surgery reaches its target. It reassures patients that they are taken care of in the right manner.”