Galen Robotics nets FDA de novo clearance for ENT surgery helper

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

Galen hopes to eliminate some of the larger upfront capital costs that may deter surgical practices from making their first investments in robotics, instead offering the ES system through an on-demand, pay-per-use model.

The company collected $15 million in venture capital funding last November, in a round led by Ambix Healthcare Partners, to help finalize its ES prototype and complete its submissions to the FDA. Galen previously said it plans to have its device initially target laryngological procedures, before tackling additional ENT, neurosurgery, spine and cardiothoracic indications. 

"Because the pandemic wreaked havoc on hospital profits with elective surgeries being postponed, we had to pivot our business model from hospitals paying up front for capital equipment to ‘as a service,’” Bruce Lichorowic, Galen’s president and CEO, said last fall in the company’s announcement of its series A fundraising. 

Those proceeds were also slated to help expand its clinical sales team and develop surgeon training programs.

"We watched this team take an early surgical robotic prototype from Johns Hopkins University's Robotics Lab, develop it into a potential game changer, and submit it to FDA, all during a pandemic,” Aaron Berez, managing director of Ambix Healthcare Partners, said last November.