Medrobotics Corporation Receives FDA Clearance to Market Flex® Robotic System
Company Initiates U.S. Launch of the Flex Robotic System for Transoral Procedures in the Mouth and Throat
RAYNHAM, Mass.--Medrobotics Corp., a surgical robotics company, announced today it has received FDA clearance to market the Flex Robotic System and is initiating commercial launch in U.S. hospitals. It received European CE mark clearance in March 2014.
"The Flex Robotic System is the first and only robot-assisted surgical platform with a flexible scope cleared by FDA for use during transoral procedures," said Samuel Straface, Ph.D., president and CEO of Medrobotics. "The minimally invasive system enables surgical access and visualization in hard-to-reach locations through a single site. Doctors can then complete procedures that might otherwise be difficult, or even impossible, to perform due to inability to visualize or access the site."
Unlike traditional "line-of-sight" approaches, the Flex Robotic System employs a unique, flexible, robotic scope that precisely moves through the bodys natural twists and turns. Once the surgeon reaches the desired vantage point, the scope becomes rigid to form a stable surgical platform. The on-board, high definition vision system makes it easy to see and operate with a range of flexible surgical instruments. The unique "wristed" 3mm Flex Instruments allow the surgeon to operate precisely in confined spaces.
"The Flex Robotic System provides unparalleled access and visualization of the oropharynx, hypopharynx and larynx," said Dr. Marshall Strome, Professor and Chairman Emeritus, Cleveland Clinic Head and Neck Institute and Co-Chair of Medrobotics Medical Advisory Board. "When used in combination with the highly adjustable Flex Retractor, surgeons can greatly extend their reach in challenging areas of the mouth and throat. I consider these products transformative."
University of Pittsburgh Medical Center Distinguished Professor and Emeritus Chair of Otolaryngology, and Co-Chair of Medrobotics Medical Advisory Board, Eugene Myers, M.D., echoed those comments. "Ive been a surgeon since 1960 and this technology is one of the most significant operating room advances Ive seen in decades. If surgeons can reach a site, they can do some good. The Flex Robotic System makes that possible in a number of head and neck procedures. Further, with this device, the surgeon is positioned close to the patient throughout the procedure. My strong sense is it will also have applications for surgery in other sites."
Minimally invasive surgery has demonstrated advantages for patients and providers compared to traditional open procedures, decreasing hospital stays and recovery times. The Flex Robotic System was designed to provide an affordable, easy-to-use robot-assisted surgical platform for hospitals and surgeons seeking to provide minimally-invasive treatment options to the broadest number of patients possible.
About Medrobotics
Medrobotics Corporation (www.Medrobotics.com) is a privately-held company headquartered in Raynham, Massachusetts. It manufactures and markets the Flex Robotic System that was pioneered at Carnegie Mellon University in Pittsburgh, Pennsylvania. This unique, robot-assist surgical platform provides surgeons with single-site access and visualization of hard-to-reach anatomical locations. The Companys vision is to provide more patients with access to minimally invasive surgery. Medrobotics received the CE mark for its Flex Robotic System in March 2014. It has been available on a limited basis in Europe since June 2014. The Flex Robotic System was cleared for sale in the U.S. by the FDA in July 2015.
Featured Product
FLIR Si1-LD - Industrial Acoustic Imaging Camera for Compressed Air Leak Detection
The FLIR Si1-LD is an easy-to-use acoustic imaging camera for locating and quantifying pressurized leaks in compressed air systems. This lightweight, one-handed camera is designed to help maintenance, manufacturing, and engineering professionals identify air leaks faster than with traditional methods. Built with a carefully constructed array of MEMS microphones for high sensitivity, the Si1-LD produces a precise acoustic image that visually displays ultrasonic information, even in loud, industrial environments. The acoustic image is overlaid in real time on a digital image, allowing you to accurately pinpoint the source of the sound, with onboard analytics which quantify the losses being incurred. The Si1-LD features a plugin that enables you to import acoustic images to FLIR Thermal Studio suite for offline editing, analysis, and advanced report creation. Field analysis and reporting can also be done using the FLIR Acoustic Camera Viewer cloud service. Transferring of images can be managed via memory stick or USB data cable. Through a regular maintenance routine, the FLIR Si1-LD can help facilities reduce their environmental impact and save money on utility bills.
