Technology | February 24, 2012

FDA Clears Invendo Advancement-Assisted Single-Use Colonoscopy System

February 24, 2012 — Invendo Medical announced today that the company received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the company's new C20 colonoscopy system including the SC20 single-use colonoscope.

The Invendoscope SC20 has several features new to the field of colonoscopy:

  • It is a single-use colonoscope with a working channel;
  • It is not pushed or pulled, but uses a computer-assisted gentle drive technology;
  • All endoscopic functions are performed using a handheld device; and
  • It reduces forces on the colon wall.

A clinical trial with the company's colonoscope delivered convincing results with a more than 98 percent cecal intubation rate and lesions detected in 41 percent of screening subjects. No device-related adverse events were observed during the study.

The C20 colonoscopy system has already received the CE mark in Europe.

"We are very proud to have achieved the most significant milestone in our company's history so far," said Berthold Hackl, CEO of Invendo Medical. "We are extremely excited to be bringing this new colonoscopy system to the U.S. market.  We believe that the invendo system reduces the burden associated with current conventional systems and that it may help to improve colonoscopy compliance rates, one of the key factors affecting the future incidence of colorectal cancer."

For more information: www.invendo-medical.com

Related Content

Infrared Colitis Screening Blood Test Could Reduce Dependence on Colonoscopy
News | Colonoscopy Systems | August 31, 2017
August 31, 2017 — A fast, simple blood test for ulcerative colitis using infrared spectroscopy could provide a cheape
Insurance Coverage for CT Colonography Increases Likelihood of Screening
News | Colonoscopy Systems | July 12, 2017
People with insurance policies that cover computed tomography (CT) colonography for colorectal cancer screening are...
CT colonography (CTC) allows visualization of the entire colon in one image

CT colonography (CTC) allows visualization of the entire colon in one image. Photo courtesy of Judy Yee, M.D.

Feature | Imaging | July 05, 2017 | By Jeff Zagoudis
Computed tomography colonography (CTC), also known as virtual colonoscopy, offers a noninvasive alternative to...
Technology | Colonoscopy Systems | March 27, 2017
March 27, 2017 — Bracco Diagnostics Inc. announced the launch of its PROTOCO2L TOUCH Colon Insufflator.
CT colonography, patient and provider groups, Congress, screening, H.R. 1298
News | Colonoscopy Systems | March 02, 2017
Major colorectal cancer care advocacy groups and medical societies have released a statement strongly urging Congress...
Affordable Care Act, economic disparities, mammography, colonoscopy, cancer screening
News | Business | February 08, 2017
Out-of-pocket expenditures are thought to be a significant barrier to receiving cancer preventive services, especially...
Check-Cap, C-Scan system, colorectal cancer screening, clinical trial, CE Mark
News | Colonoscopy Systems | January 31, 2017
Check-Cap Ltd. recently announced the enrollment of the first patient in its multi-center study of the C-Scan system in...
News | Colonoscopy Systems | January 26, 2017
Researchers have developed the first sensor capable of objectively identifying inflammatory bowel disease (IBD) and...
Given, Pillcamp, colonoscopy, Angiodysplasias, capsule Endoscopy, LVAD interference

The Given Imaging PillCam Colon system is an example of a capsule endoscopy device the patient swallows to image the gastrointestinal track.

Feature | Endoscopes | January 03, 2017 | Anamika Kumari
The capsule endoscopy systems offer a hands-free and highly accurate imaging modality for healthcare practitioners.
Overlay Init