medical device guru

FDA Grants GI Windows Medical Breakthrough Device Designation for Magnetic Anastomosis Technology

Imaging Visualization & Navigation October 1, 2020

GI Windows Medical Corp, a clinical-stage, privately-held medical device company pioneering new advancements in anastomosis technology announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the self-forming magnetic compression anastomosis device indicated for small bowel end to end anastomosis for ileostomy reversal or tissue resection.

The Breakthrough Devices Program is a voluntary program for select medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide GI Windows with priority review and interactive communication regarding device development and clinical trial protocols, during the premarket review process.

“GI Windows has developed a compelling technology that may provide several significant benefits for our patients with colorectal disease,” said Dr. Christopher Thompson, Director of Endoscopy, Professor of Medicine Harvard Medical School at Brigham & Women’s Hospital, “This is an exciting time in healthcare with the FDA working closely with the companies designated as having disruptive technology, to help improve the access for our patients.”

The GI Windows technology is designed to help surgeons deliver less invasive solutions via magnetic compression anastomosis, allowing clinicians to improve patient outcomes and reduce healthcare costs by creating new capabilities in healthcare.

“This designation is a major milestone for GI Windows, as we aspire to change the paradigm in anastomosis creation throughout the GI tract. Our entire team has worked hard in developing the technology and evidence to achieve this designation from the FDA,” said Brian Tinkham, President & CEO of GI Windows. “We look forward to working collaboratively with the FDA to help prioritize development and access for patients.”

See Full Press Release at the Source: U.S. FDA Grants GI Windows Medical Corp Breakthrough Device Designation for Magnetic Anastomosis Technology


Press Release by: GI Windows Medical Corporation


Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

AUTHOR - Authorship Credit Noted Above
SHARE
YOUR FIRST STEP TO SUCCESS
IS JUST A CLICK AWAY
Search our current open opportunities to take your first step to success in Medical Device and Healthcare IT today. Focusing on you and your career is our Job, now it’s time for you to find yours. Let’s get started.
VIEW JOBS