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Lumendi Nabs FDA Clearances for 2 New Devices
DiLumen EZ1 and C1 are part of a growing platform of accessories.
Sam Brusco, Associate Editor
02.17.23
Lumendi Introduces its EZ Glide Hydrophilic Coating
The coating is activated by water or saline and improves endoscopic performance of the DiLumen EIP.
Michael Barbella, Managing Editor
05.07.21
Surgical
FDA OKs Lumendi's DiLumen Ik Endolumenal Interventional Knife
1000 therapeutic procedures using DiLumen EIP have been completed across the U.S., Europe, and Asia.
Business Wire
08.20.19
Lumendi Receives FDA 510(k) Clearance for Innovative DiLumen EIP Device Modification
Modification improves endoscopists’ ability to dissect and ultimately resect polyps without surgical intervention.
Business Wire
12.27.18
Five Hundred Therapeutic Procedures Using DiLumen EIP Completed Across U.S., Europe, Asia
The first procedure with DiLumen in Asia was performed recently at Chinese University of Hong Kong.
Business Wire
11.08.18
Lumendi Receives CE Mark for DiLumen EIP
To date, more than 400 procedures have been performed in the United States with the DiLumen EIP.
Business Wire
08.27.18
Lumendi Receives FDA 510(k) Clearance for DiLumen Is Endolumenal Interventional Scissors
Complete platform of accessories now available for gastrointestinal endolumenal procedures.
Business Wire
07.11.18
Lumendi Receives FDA 510(k) Clearance for Dilumen C2
Second-generation endoscopic accessory is designed for endolumenal procedures.
Business Wire
05.25.18
Surgical
FDA Clears Lumedi's Second Generation Endoscopic Accessory for Endolumenal Procedures
The device allows surgeons to perform complex procedures completely within the colon without open surgery.
Business Wire
04.23.18
Lumendi Reports Successful Completion of DiLumen EIP First-in-Human Trials
Primary study endpoint reached with no serious adverse events.
Business Wire
12.14.17
Lumendi Receives FDA Clearance to Market DiLumen for Endolumenal Therapy
Platform developed by Lumendi with leaders at New York-Presbyterian and Weill Cornell Medicine’s MINT program.
Business Wire
12.15.16
FDA Clears Lumendi's DiLumen for Endolumenal Therapy
Device was developed with digestive disease leaders at New York-Presbyterian and Weill Cornell Medicine’s MINT program.
Business Wire
12.13.16
Breaking News
ISO 13485 Certification Awarded to Scherdel Medtec North America
FDA Clears AIOMEGA’s Sleep Apnea Treatment Solution
Empatica Initiates AI Seizure Forecasting Study With Debut of Epilepsy Watch
Enrollment Complete in Study of FIRE1's Remote Heart Failure Monitoring System
Medtronic Releases Avalus Ultra Surgical Aortic Tissue Valve
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
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