RAYNHAM, Mass.--(BUSINESS WIRE)--Medrobotics Corp., a medical robotics company, announced today it has received FDA regulatory clearance to market the Flex® Robotic System for robot-assisted visualization in general surgical, gynecological and thoracic procedures in the United States. This clearance reaffirms the Company’s progress to develop transformative products for single-port general, gynecological, thoracic and urological surgeries.
“With this new FDA indication, the use of Medrobotics’ flexible robotic technology extends beyond natural orifices,” said CEO Samuel Straface, Ph.D. “This clearance is a vital step in our commitment to minimize the impact of surgery by offering less invasive procedures through a single incision in the abdomen or thoracic cavity versus the multiple incisions that are currently required.”
Medrobotics markets the Flex® Robotic System, the world’s first and only robotic surgical platform which provides Scarfree™ access to hard-to-reach anatomy in otolaryngology and colorectal procedures. The Company is also pursuing expansion of applications to other areas including transvaginal gynecologic procedures.
The award-winning Flex® Robotic System has been widely recognized for advances in surgical robotic technology, including Best-in-Show at the 2016 Medical Design Excellence Awards (MDEA) and a Best New Product at the 2017 Edison Awards. The mobility and short learning curve of the Flex® Robotic System offer the promise of scheduling flexibility and efficiency not seen with other surgical systems. Patients who seek care from hospitals with comprehensive robotics programs that include the Flex® Robotic System may enjoy the best chance for the least invasive treatment of their condition.
Medrobotics Corporation (www.Medrobotics.com) is a privately funded medical device company headquartered in Raynham, Massachusetts. It manufactures and markets the Flex® Robotic System, the world’s first robotic surgical platform with a steerable and shapeable robotic scope. The Flex® Robotic System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point while operating in hard-to-reach anatomical locations that might otherwise be inaccessible with straight, rigid surgical tools. The Company’s vision is to provide more patients with access to Scarfree™ surgical options. Medrobotics received FDA clearances for the Flex® Robotic System for ENT applications in July 2015 and for colorectal surgery in May 2017. The CE mark was issued in March 2014.