Medical
The FDA gave Vicarious's robot breakthrough device designation, a program meant to speed up review. This is not a clearance.
A dated step forward on the record · Company-reported
What the source says
“The SPAC deal comes nearly a year and a half after FDA provided breakthrough device designation for Vicarious' robot”
What it means
Vicarious Surgical Robotic System, from Vicarious Surgical, is at stage 1 of 5 on our ladder: demo only. Its stage is set by other milestones on its record; this one adds to the history. 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 Vicarious Surgical Robotic System
- Shareholders voted to shut Vicarious down and liquidate it at once, and the remaining staff lost their jobs. The company had raised about $300 million in total.
- Vicarious's board asked shareholders to close and sell off the company. It said it could not raise more money or find a buyer.
- The New York Stock Exchange began removing Vicarious's stock because the company's market value had fallen below the minimum.
- Vicarious finished a test operation on pigs, its first animal cases in several years, and set a final design for the end of 2026.
- Vicarious had aimed for first human trials by mid-2025, but in August 2025 it said it would hold off to keep developing the robot.
- Vicarious agreed to go public through a $1.1 billion merger with a shell company (a SPAC). Backers included Bill Gates and Khosla Ventures.