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Intuitive wins FDA clearance to enhance scanning integration for Ion Endoluminal procedures


Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced the U.S. Food and Drug Administration has cleared the integration of a 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 help improve biopsy tool placement.

Early studies have shown Ion enables a diagnostic yield of approximately 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%1 when the Cios Spin was used with the Ion platform.

This new imaging integration could help improve the accuracy of biopsy procedures, a key step in how lung cancer gets diagnosed. Lung cancer kills more people annually than any other cancer2 and early diagnosis can improve survival rates. The integration enhances a physician’s ability to provide minimally invasive lung biopsy with the Ion system, which can give patients answers sooner.

“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,” said Charlie Dean, senior vice president of Endoluminal at Intuitive. “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, vice president 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.”

 Definitions of diagnostic yield may vary across publications. Information provided is directional in nature and is not conclusive, and may not be reproducible or generalizable.


Source: Intuitive.

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