RTP robotic surgical firm Asensus clears big regulatory hurdle in European Union

RESEARCH TRIANGLE PARK – It may not be rocket science, but you could argue that Asensus Surgical’s Intelligent Surgical Unit (ISU) is pretty close to it.

The Research Triangle Park-based medical device company, which changed its name from TransEnterix in early 2021, is pioneering the use of robotics to improve minimally invasive surgery with the help of artificial intelligence, image enhancement, 3D measurement and digital tagging. And its technology is gaining traction. Asensus said the expansion of machine vision capabilities to its previously cleared Senhance ISU has just received CE Mark.

This approval is granted by the European Union’s Medical Device Regulation (MDR), a new set of requirements that govern the clinical investigation, production and distribution of medical devices in Europe. The FDA provided a similar clearance in September 2021 and the ISU also is available for use in Japan.

Asensus

Asensus said the MDR endorsement included a review of the Senhance Surgical System laparoscopic platform, making it one of the first robotic surgical technologies to be authorized by the more rigorous European Union (EU) process.

“We are thrilled to be able to offer these ground-breaking ISU capabilities to surgeons in the EU,” said Anthony Fernando, the company’s president and CEO. “Surgeon feedback from the expanded feature set across the U.S. and Japan has been tremendous, and we look forward to partnering with new and existing customers to help bring real-time intraoperative digital tools into operating rooms throughout Europe.”

The Asensus ISU isn’t your father’s medical technology. It’s designed to give physicians an improved view of the surgical landscape during laparoscopic procedures. The ISU responds to the physician’s commands and recognizes certain objects and locations in the surgical field. An upgraded automated camera control has new zooming and panning capabilities and adds 3D measurement and digital tagging features to the system. It also can enhance images by automatically adjusting the brightness and contrast of the camera’s view.

The 3D measurement feature allows surgeons to mark points on tissue and throughout the abdominal cavity and get instant and accurate readings of the distance between those points. Digital tagging enables doctors to virtually flag areas of interest within a patient’s anatomy so it’s easier to keep track of those areas during a procedure.

Asensus’ web page says the company’s Senhance Surgical System “is turbocharging the digital laparoscopy landscape, providing surgeons with an unprecedented level of control, integrating innovative technological advances to help surgery become more instinctive, more responsive and more focused.”

The regulatory agencies in Europe, the U.S., Japan and several other countries seem to agree on its benefits.

(C) N.C. Biotech Center

The post RTP robotic surgical firm Asensus clears big regulatory hurdle in European Union first appeared on WRAL TechWire.

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