Regulator
The FDA cleared two more Maestro features, including a wireless link to the company's cloud data service, Maestro Insights.
A regulator's decision · Company-reported · Sets Maestro's stage
What the source says
“received FDA 510(k) clearance for two new features on the Maestro robotic surgical assistant.”
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. 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 Maestro
- Moon Surgical and the surgical-equipment maker KARL STORZ agreed to sell and use their products together.
- 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.
- The FDA cleared the first version of Maestro through the 510(k) route (K221410).