SOUTH CAROLINA – October 15, 2024 – Johnson & Johnson Medtech announced that it filed an FDA 510(k) submission for the latest Monarch platform software release.
The New Brunswick, New Jersey-based medtech giant designed the Monarch surgical robotic system to provide bronchoscopic visualization of and access to adult patient airways. Uses include diagnostic and therapeutic procedures.
Monarch enables the use of minimally invasive, robotic-assisted technology for peripheral lung procedures. This could improve the ability to access small, hard-to-reach peripheral lung nodules at an earlier stage and with greater precision.
Johnson & Johnson initially acquired Monarch when it bought Auris for $3.4 billion in 2019, entering the robotic surgery market. It already held FDA clearance for bronchoscopy and picked up clearance for endourological procedures in 2022. Late last year, Monarch became the first minimally invasive, robotic-assisted technology approved for peripheral lung procedures in China.
In a post on LinkedIn, J&J wrote that its 510(k) filing includes a new key feature for the platform. Monarch now integrates an advanced C-arm imaging technology platform, the post said.
“We are working to deliver meaningful updates that customers need today and exploring innovative options to transform patient care in the future,” J&J MedTech wrote on the social media outlet.
Written by: Sean Whooley