Asensus Surgical has secured a European approval that builds upon the machine vision capabilities of its previously greenlighted robotic surgery hardware.
The CE mark, granted via the EU’s revamped Medical Device Regulation (MDR), marks the final piece necessary to fully unlock the company’s artificial-intelligence-powered options among systems across the EU, Japan and the U.S.
The approval covers the advanced features of Asensus’ Intelligent Surgical Unit, which helps operate its Senhance laparoscopic instrument platform—managing real-time image analytics and machine-vision-driven control of the surgeon’s camera—plus the ability to digitally tag and enhance the view of specific parts of the patient’s anatomy while also taking 3D measurements.
“This is a significant milestone for the company as our filing included a review of the Senhance Surgical System, both software and hardware, under the new, stricter EU MDR process,” Asensus Surgical President and CEO Anthony Fernando said in a release, adding that the clearance process took just under one year.
Asensus previously scored an FDA clearance for its advanced AI imaging features in 2021, while the Intelligent Surgical Unit itself was cleared in the U.S. in early 2020. And with a general surgery green light for the Senhance hardware and its robotic arms, the system can be used for minimally invasive laparoscopic procedures within the abdomen, such as for reconstructive surgeries to treat acid reflux, obesity and more.
Meanwhile, digital features like 3D measuring can be used to accurately plot lines of staples without estimations or the insertion of sterile tape.
In the EU, the yearslong implementation of the MDR has caused frustration among medtech makers. Late last year, a handful of companies disclosed that the new system for regulating medical devices would lead to them pulling certain products from European shelves altogether. With some items needing to go through a slow recertification process, delays and exits from the market could potentially lead to shortages.
The MDR was first introduced in 2017 and officially took effect in 2021, though devicemakers were given a three-year grace period to comply. But that timeline could be extended once more, after the European Commission earlier this month adopted a proposal to delay the MDR’s full implementation. That proposal will now make its way through the EU’s parliament and council before final approval.