Regulator
The FDA cleared Liberty through the 510(k) route, based on a study in which the robot reached its target every time with no device-related harm.
A regulator's decision · Company-reported · Sets Liberty's stage
What the source says
“Findings included 100% success in the robotic navigation to target and zero device-related adverse events.”
What it means
Liberty, from Microbot Medical, 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 Liberty