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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

TransEnterix Announces Pediatric Cases with Senhance Surgical System

TransEnterix Inc. has announced that surgeons at Maastricht University Medical Center+ (MUMC+) in the Netherlands, have successfully operated on multiple pediatric patients, becoming the first pediatric surgical program in the world to utilize the Senhance Surgical System and integrate digital laparoscopy with instruments as small as 3 mm into their standard of surgical care.

“Pediatric surgery is a field that demands precision, control and minimal invasiveness. The Senhance System is designed to maximize control of instruments as small as 3 mm and be compatible with small scopes while also retaining the sense of touch through haptic feedback,” said Anthony Fernando, president and chief executive officer of TransEnterix. “This is the first time that 3 mm instruments have been used in robotic pediatric surgery and MUMC+ is the first hospital to initiate a pediatric surgery program with Senhance. We will continue to work with their excellent surgeons to build a successful clinical program and grow the adoption of Senhance in pediatric surgery.”

“The ability to use 3 mm instruments on a robotic platform is what first drew my team to utilize the Senhance,” said Prof. Dr. Wim van Gemert, Chairman of the Department of Pediatric Surgery, MUMC+. “As we have begun to utilize the Senhance System in multiple pediatric patients, including complex reconstructive procedures, we’ve found that the haptic feedback, precision and unique vision control system are advantages to our experience. This platform has a very promising future as a tool in the hands of pediatric surgeons.”

The Senhance Surgical System is the first and only digital laparoscopic platform designed to maintain laparoscopic minimally invasive surgery standards while providing digital benefits such as haptic feedback, robotic precision, eye-sensing camera control, comfortable ergonomics, advanced instrumentation including 3 mm microlaparoscopic instruments, and reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy.

Senhance European Indication for Use

The Senhance Surgical System has received a CE Mark according to the Medical Device Directive and is intended to be used for laparoscopic surgery in the abdomen, pelvis and limited uses in the thoracic cavity excluding the heart and greater vessels. The system is indicated for adult and pediatric use in CE marked territories.

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