Regulator
The FDA cleared Ion for taking biopsies from the outer parts of the lung.
A regulator's decision · Sets Ion's stage
What the source says
“Intuitive Surgical announced Tuesday it received FDA clearance for its Ion system, which permits minimally-invasive biopsies”
What it means
Ion, from Intuitive, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: The maker hasn't said whether people help it remotely.
More on Ion
- Intuitive placed 55 Ion systems in the second quarter of 2026, up from 54 a year earlier.
- The FDA cleared new Ion software, including AI and imaging features, which Intuitive planned to release through a limited launch.
- Intuitive said more than 900 Ion systems were in hospitals across 10 countries.
- China's medical device regulator approved Ion for sale in China.
- Intuitive started a Class 2 recall of an Ion catheter because a ring at its tip could come off during a procedure.
- Intuitive said it would roll Ion out slowly in the US, with the first shipments to customers in the second quarter of 2019.