Regulator
The FDA cleared the first version of Maestro through the 510(k) route (K221410).
A regulator's decision · Sets Maestro's stage
What the source says
“secured its first 510(k) clearance from the FDA for its Maestro surgical system”
What it means
Maestro, from Moon 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.
Human help: Our sources report it working without human help.
More on Maestro
- Moon Surgical and the surgical-equipment maker KARL STORZ agreed to sell and use their products together.
- The FDA cleared two more Maestro features, including a wireless link to the company's cloud data service, Maestro Insights.
- Moon Surgical said Maestro had been used in more than 1,600 operations worldwide, 1,400 of them in the past year, as Lee Health in Florida passed 100 cases.
- The FDA cleared ScoPilot, an AI feature that makes the camera follow the tip of a chosen instrument (510(k) K242323).
- Surgeon's Point Surgery Center in Cedar Park, Texas became the first outpatient surgery center to use Maestro, with 20 patients treated.
- Baptist Health in Jacksonville, Florida did the first US operations with Maestro: weight-loss stomach surgeries.