Intuitive Surgical Submits New Robotic-Assisted Platform to FDA for Obtaining Lung Biopsies

Posted on September 06, 2018 by Medtech[y] Staff

Intuitive Surgical announced that they have submitted a premarket notification to the FDA for a new flexible robotic, assisted catheter-based platform, designed to navigate through very small lung airways to reach peripheral nodules for biopsies.

What to know -

1. The majority of suspicious lesions found in the lung are small and difficult to access, which can make obtaining a diagnosis challenging. In short, safe and effective access is a challenge. 

2. Premarket notification is one of the regulatory processes that the FDA uses to review information about medical devices before they are allowed to be marketed in the U.S.

3. The space to access lesions in the lung and to treat lung cancer is rapidly growing. There are multiple competitors working on similar technology. Having two decades of experience with robotic-assisted surgical technology should help Intuitive as they develop this new technology. 

Intuitive has perviously stated that they were working on releasing a flexible biopsy catheter designed to take tissue samples from deep within the lungs.They are working with Shanghai Fosun Pharmaceutical Group on the technology and potentially other technologies as well. 

Here is a quick video describing the capabilities of the new flexible biopsy catheter:

Potential Competing Technologies

Auris Health Monarch Platform

The Auris Monarch Platform seeks to leverage the power of flexible robotics to enable new possibilities in endoscopy, which uses small cameras and tools to enter the body through its natural openings. The Monarch also uses an Xbox inspired controller to navigate the flexible robotic endoscope to the periphery of the lung.

The Auris Monarch system was approved earlier this year and covers the use of the device in the diagnosis and treatment of lung cancer.