Medical
Globus began selling ExcelsiusGPS in the US at the end of 2017.
A dated step forward on the record · Company-reported
What the source says
“Surgeons and hospital administrators in the United States have shown tremendous levels of interest in ExcelsiusGPS® since it first launched domestically at the end of 2017”
What it means
ExcelsiusGPS, from Globus Medical, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. Its stage is set by other milestones on its record; this one adds to the history. 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 ExcelsiusGPS
- The FDA cleared a sister robot, ExcelsiusFlex, for knee replacement and other joint surgery.
- Globus recalled 9 kits of an add-on part used with ExcelsiusGPS for X-ray imaging, because a calibration error could make the navigation inaccurate and a screw could be placed in the wrong spot. The FDA listed it as a Class 1 recall (its most serious kind).
- Globus said surgeons had done more than 20,000 spine operations with ExcelsiusGPS.
- The first European operation with ExcelsiusGPS took place at Metropolitan Hospital in Athens, Greece.
- The FDA cleared ExcelsiusGPS through the 510(k) route (K171651) for open and minimally invasive spine and orthopedic surgery.