Regulator
The FDA cleared Monarch Quest 3, a new software update for finding and reaching lung spots.
A regulator's decision · Company-reported · Sets Monarch's stage
What the source says
“Johnson & Johnson today announced U.S. 510(k) regulatory clearance for MONARCH™ QUEST 3”
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.
More on Monarch
- Monarch was used for the first time in the Middle East, at Cleveland Clinic Abu Dhabi.
- Johnson & Johnson bought Monarch's maker, Auris Health, for $3.4 billion in cash, with up to $2.35 billion more if goals were met.
- The FDA cleared Monarch for lung procedures in 2018. By late 2020 it had been used in more than 4,000 airway (bronchoscopy) cases.