Regulator
The FDA granted Ottava De Novo authorization for 10 general surgery operations in the upper belly, including gastric bypass, gallbladder removal and hiatal hernia repair.
A regulator's decision · Company-reported · Sets Ottava's stage
What the source says
“the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the OTTAVA™ Robotic Surgical System”
What it means
Ottava, from Johnson & Johnson, 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 Ottava
- A separate US clinical trial of Ottava for groin (inguinal) hernia repair was still going on.
- Surgeons did the first operations with Ottava, gastric bypass surgeries, as part of the US clinical trial.
- The FDA allowed Johnson & Johnson to start a US clinical trial of Ottava (an investigational device exemption).
- Johnson & Johnson pushed back the first human trials of Ottava by two years, to the second half of 2024, citing COVID-19 and supply problems.
- Johnson & Johnson gave the first public look at Ottava.