Intuitive, Siemens Earn FDA Nod for Ion Endoluminal

Intuitive and Siemens Healthineers have earned U.S. Food and Drug Administration (FDA) clearance for integration of Siemens’ mobile cone-beam CT (CBCT) imaging technology and the Ion Endoluminal System used for robotic-assisted bronchoscopy.
 
Siemens Healthineers Cios Spin mobile imaging offers integrated functionality with Ion to provide 2D and 3D imaging during procedures to help physicians gain confidence around refining Ion’s catheter positioning and improve biopsy tool placement.
 
Early studies showed Ion enables diagnostic yield of about 80% in studies with a relatively small average nodule size. 3D imaging is used in peripheral nodule biopsies to confirm that biopsy tools are appropriately placed in a suspicious nodule. An initial single center study demonstrated an improvement in diagnostic yield of up to approximately 10% when the Cios Spin was used with the Ion platform.
 
“Since launching Ion we have continued to make improvements to our system, tools and user interface with a view of making robotic-assisted lung biopsy the standard of care,” Charlie Dean, senior VP of Endoluminal at Intuitive told the press. “With the Siemens Healthineers integration we are raising that bar further by enabling our physicians to even more accurately and repeatably biopsy small lesions deep within the lung. With this clearance, we hope to help physicians continue to improve patient outcomes.”
 
Ion will continue to evolve with the potential inclusion of other technology collaborators to enhance its ecosystem in ways physicians and care teams find valuable.
 
“The integration between Ion and Siemens Healthineers’ Cios Spin provides additional information that may help physicians gain more confidence that they are collecting tissue at the right location,” said Dr. Oliver Wagner, VP and Ion’s medical officer. “There’s clear patient benefit in these technologies working together to help improve accuracy, which could help get answers sooner.”