Medrobotics® Corporation krijg toestemming van FDA voor ‘s werelds eerste en enige transabdominale en transthoracale kijkrobot
Bedrijf krijgt toestemming om robotsysteem Flex® op de markt te zetten voor visualisatie bij algemene chirurgische, gynaecologische en thoracale ingrepen
RAYNHAM, Mass.–(BUSINESS WIRE)– Medrobotics Corp., een bedrijf in medische robotica, heeft vandaag bekendgemaakt dat de FDA wettelijke toestemming heeft gegeven voor de verkoop van het Flex® Robotic System, dat bij algemene chirurgische, gynaecologische en thoracale operaties in de Verenigde Staten visuele ondersteuning biedt. Deze vergunning onderstreept wederom de vooruitgang die het bedrijf boekt bij de ontwikkeling van producten die bijdragen aan algemene, gynaecologische, thoracale en urologische operaties met één incisie.
“Met deze nieuwe indicatie van de FDA gaat de inzet van de flexibele robottechnologie van Medrobotics verder dan louter natuurlijke lichaamsopeningen”, zei Samuel Straface, Ph.D. “De toestemming is een cruciale stap voor ons streven naar minimale impact van operaties, door middel van minder invasieve procedures met een enkele incisie in de onderbuik of borstholte, in tegenstelling tot het veelvoud aan incisies dat momenteel is vereist.”
Medrobotics® Corporation Receives FDA Clearance for World’s First and Only Flexible Transabdominal and Transthoracic Robotic Scope
Company Now Cleared to Market Flex® Robotic System for Robot-Assisted Visualization in General Surgical, Gynecological and Thoracic Procedures
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.
About Medrobotics
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180121005126/en/
Contacts
Media:
For Medrobotics Corporation
Kevin Knight, 214-732-9392
kknightpr@gmail.com