Navigation Links
invendo medical Files 510(K) Notice With FDA for Clearance of the Computer-Assisted Colonoscopy System

NEW YORK and KISSING, Germany, March 8 /PRNewswire/ -- invendo medical announced today that the company has filed its 510(k) notice submission with the Food and Drug Administration for premarket clearance of the company's new C20™ colonoscopy system including the SC20™ single-use colonoscope. This is the first FDA submission for invendo medical in the United States.

The pivotal clinical trial with the company's single use, advancement-assisted colonoscope in 61 screenees has been completed in December 2009 with encouraging results. The device achieved a 98% cecal intubation rate (60 of 61 subjects), and, while sedation was available to all subjects and doctors upon request, less than 5% of the subjects requested a sedative during the study procedure. There also were no device-related adverse events observed during the study. Lesions were detected in 41% of the subjects.

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

"Our initial commercial focus will be on the United States," said Berthold Hackl, CEO of invendo medical, "Therefore the submission for 510(k) clearance of our new colonoscopy system marks a major milestone in our company's history. We will give the further process with the U.S. Food and Drug Administration our full attention."

About invendo medical -

Based in New York, U.S.A. and Kissing (near Munich), Germany, invendo medical is a leading developer of disposable endoscopy products in the field of gastroenterology that are hygienically safe and employ "no manual push" remote control advancement technology.


SOURCE invendo medical

Back to top



SOURCE invendo medical
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. National Instruments Awards $1 Million to Advance Medical Device Development Since 2008
2. Rcadia Medical Imaging’s COR Analyzer(R) System Receives CE Mark
3. Millstone Medical Outsourcing Announces Addition of New Director of Manufacturing Engineering
4. Home Medical Equipment Providers and Lawmakers Discuss Cost-Effective Role of Homecare During Washington Meeting
5. ProUroCare Medical Elects Two New Directors
6. ReShape Medical Announces Initiation of U.S. Clinical Study for Weight Loss
7. DEP Urges Medical Facilities to Take Proper Precautions With X-Ray Equipment to Avoid Health Hazards
8. FDA Provides 510k Clearance for BARRX Medicals HALO90 Ablation Catheter for the Treatment of Radiation Proctitis and Gastric Antral Vascular Ectasia (GAVE)
9. New Research from Best Practices, LLC Helps Medical Device Companies Earn the Highest Profit Possible During Their Products Patent Lifecycle
10. Cantel Medical Corp. To Hold Conference Call To Discuss Results For Its Second Quarter Ended January 31, 2010
11. Corgenix Medical Corp. Announces Launch of Products for Automated Systems
Post Your Comments:
(Date:12/1/2015)... --> --> ... by Type of Drug (Monoclonal Antibodies, Interferon-Alpha, Interleukins, Vaccines, (Therapeutic ... Analysis - Global Forecast to 2020", published by MarketsandMarkets, the ... Million by 2020 from USD 40,281.6 Million in 2015, at ... Browse 37 market data T ...
(Date:12/1/2015)... Pharma Tech Outlook recently conducted a comprehensive ... Management Solution Providers - 2015 .  After careful consideration ... CIOs, VCs, analysts, and the Pharma Tech Outlook editorial ... 10 clinical data management solution providers (check out the ... 36 respectively). --> ...
(Date:12/1/2015)... Ohio , Dec. 1, 2015 ... to its GeneSight® Psychotropic test giving healthcare providers an ... medication decisions for patients suffering from depression, anxiety, ... other behavioral health conditions. i ... --> With the addition of two ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... The workstation boundaries for ... IMAGE Information Systems launches MED-TAB™ -- the world’s first portable DICOM-calibrated medical image ... 29 to December 4, 2015. , MED-TAB is expected to change teleradiology ...
(Date:12/1/2015)... ... , ... The importance of volumetric breast density assessment for ... abstracts accepted for presentation here, at the 101st Annual Radiology Society of North ... of Volpara Solutions’ quantitative breast imaging software tools for providing breast imaging and ...
(Date:12/1/2015)... ... December 01, 2015 , ... For ... That is why Hollister Incorporated has launched the VaPro Plus Pocket™ touch free ... in the VaPro touch free catheter portfolio,” said Michael Gresavage, Vice President North ...
(Date:12/1/2015)... ... December 01, 2015 , ... SAN FRANCISCO, Calif. (December 1, ... organization has awarded Education and Developmental Therapies (EDT), an Applied Behavior Analysis (ABA) ... exceptional special needs providers that excel in synthesizing the areas of clinical quality, ...
(Date:12/1/2015)... ... December 01, 2015 , ... McLean, ... been awarded a fixed price per sprint agile development contract to support the ... million over five years, provides software engineering, infrastructure, as well as operations and ...
Breaking Medicine News(10 mins):