Navigation Links
invendo medical Files 510(K) Notice With FDA for Clearance of the Computer-Assisted Colonoscopy System
Date:3/8/2010

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 - www.invendo-medical.com

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.

web: www.invendo-medical.com

SOURCE invendo medical

Back to top

RELATED LINKS
http://www.invendo-medical.com

'/>"/>

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:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):