FDA clears Siemens Healthineers mobile 3D imaging arm
- Siemens Healthineers said Tuesday FDA cleared for marketing its mobile system that takes 2D and 3D images for quality assurance during surgery.
- The Cios Spin mobile arm offers 3D computed tomography (CT)-like imaging for orthopedic, trauma and spine surgery, the medical equipment maker said.
- The system is designed to help surgeons work with greater precision and reduce rates of revision surgery as well as the need for follow-up CT scans by providing intraoperative evaluations.
Parent Siemens sold a 15% stake in its medical imaging equipment business in a successful initial public offering in Germany in March. Since then, the company has been focused on a number of new product developments.
The mobile 3D imaging system is at the center of a technology partnership that Siemens Healthineers announced in August with spinal device maker NuVasive. The aim of that partnership is to improve visualization of the anatomy during spine implant placement and jointly develop other 3D imaging and navigation tools, the companies said at the time.
In another development, Siemens Healthineers last month said FDA cleared its latest 1.5 Tesla magnetic resonance imaging (MRI) scanner, called the Magnetom Sola, aimed at reducing variations in patient imaging, shorten scan times and decrease the need for rescans.
With its latest product to gain FDA clearance, Siemens Healthineers said it is leveraging its expertise in mobile X-ray imaging. The Cios Spin supports both 2D and 3D imaging for a variety of procedures, including vascular imaging, the company said. Surgeons can perform intraoperative corrections based on the images and confirm their results. The system includes NaviLink 3D digital navigation and flat panel technology, and is available with a range of optional software packages.
The system's high generator power also addresses the challenge of imaging large patients and dense anatomy and comes with an antimicrobial coating for infection control.
Siemens Healthineers' imaging unit has outperformed its diagnostics business this year amid the latter's launch of an immunoassay and clinical chemistry analyzer called Atellica. Reuters reported Siemens Healthineers this week projected 2019 sales growth in a range of 4% to 5% as shipments of the Atellica machine pick up and demand increases for its products in China.
- Siemens Healthineers Siemens Healthineers Announces FDA Clearance of Cios Spin Mobile 3D C-Arm