Regulator
The FDA cleared a CyberKnife add-on through the 510(k) route that lets doctors treat lung tumors without first implanting small marker seeds.
A regulator's decision · Company-reported · Sets CyberKnife's stage
What the source says
“has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Lung Optimized Treatment”
What it means
CyberKnife, from Accuray, 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. This line rests on the company's own announcement; no regulator, customer or independent report confirms it in our sources yet.
Human help: Our sources report it working without human help.
More on CyberKnife
- Accuray spent $16.2 million on restructuring in its 2026 fiscal year.
- Accuray's new product orders fell to $191.9 million in its 2026 fiscal year, from $288.0 million a year before. The figure covers all of Accuray's machines, not only CyberKnife.
- Accuray marked its 200th CyberKnife installation.
- The FDA cleared CyberKnife through the 510(k) route to treat tumors anywhere in the body where radiation is called for.
- The FDA cleared CyberKnife to treat tumors in the head and neck.