The US Food and Drug Administration (FDA) has granted clearance to Siemens Healthineers for its Luminos x-ray and fluoroscopy systems. The Luminos family of systems offers a range of configurations to support various clinical applications, including general radiography, fluoroscopy, and orthopedic and trauma imaging.
The clearance encompasses the Luminos Fusion, Luminos Agile, and Luminos Fusion MAX, which are designed to provide high-quality images while minimizing radiation exposure. These systems feature advanced technologies such as artificial intelligence (AI) and machine learning algorithms to enhance image acquisition and processing.
Key features of the Luminos systems include advanced image processing software, a high-resolution detector, and a user-friendly interface. The systems also offer a range of dose-reduction technologies, including calcium scoring and functional imaging, to help minimize radiation exposure while maintaining image quality.
The FDA clearance of the Luminos x-ray and fluoroscopy systems is expected to expand the availability of these advanced imaging technologies to healthcare providers in the US. Siemens Healthineers plans to make the Luminos systems available to US customers in the coming months.
The clearance is a significant milestone for Siemens Healthineers, as it demonstrates the company’s commitment to delivering innovative imaging solutions that meet the evolving needs of healthcare providers. The Luminos systems are designed to support a wide range of clinical applications, from general radiography to specialized procedures such as orthopedic and trauma imaging.
The FDA clearance is based on a review of the safety and effectiveness of the Luminos systems, as well as their compliance with applicable regulatory requirements. The agency’s clearance process involves a rigorous evaluation of the system’s design, testing, and clinical validation to ensure that it meets the necessary standards for safety and performance.
The Luminos x-ray and fluoroscopy systems are designed to provide high-quality images while minimizing radiation exposure, making them an attractive option for healthcare providers seeking to improve patient care while reducing radiation risks. With the FDA clearance, Siemens Healthineers is well-positioned to expand its presence in the US market for x-ray and fluoroscopy systems, and to support the growing demand for advanced imaging technologies.
Overall, the FDA clearance of the Luminos x-ray and fluoroscopy systems represents a significant advancement in medical imaging technology, and is expected to have a positive impact on patient care and outcomes.