Regulator
The FDA granted Versius marketing authorization through the De Novo route, for gallbladder removal in adults 22 and older.
A regulator's decision · Company-reported · Sets Versius's stage
What the source says
“Versius granted marketing authorization through FDA’s De Novo process.”
What it means
Versius, from CMR Surgical, 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: The maker hasn't said whether people help it remotely.
More on Versius
- Stryker agreed to invest about $400 million in CMR Surgical and become the only sales agent for Versius in the US. Stryker also got an option to buy the whole company later. The deal still needs regulatory approval.
- CMR asked the FDA to clear Versius Plus for gynecologic surgery.
- CMR launched Versius in the US and said more than 45,000 patients worldwide had been treated with it.
- The FDA cleared the newer Versius Plus through the 510(k) route, also for gallbladder removal.
- CMR Surgical raised more than $200 million from existing investors and new investor Trinity Capital.