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Regulator

The FDA cleared Monarch for lung procedures in 2018. By late 2020 it had been used in more than 4,000 airway (bronchoscopy) cases.

A regulator's decision · Company-reported · Sets Monarch's stage

What the source says

“J&J has performed more than 4,000 bronchoscopy cases with the Monarch robot, cleared by FDA in 2018”
MedTech Dive, 20 Nov 2020

What it means

Monarch, from Johnson & Johnson (Auris Health), 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.