• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Pixium Vision wins CE Mark for Iris II retinal prosthesis

Pixium Vision wins CE Mark for Iris II retinal prosthesis

July 27, 2016 By Fink Densford

Pixium VisionFrench retinal implant maker Pixium Vision said Monday it won CE Mark approval in the European Union for its Iris II bionic vision system designed for individuals with vision loss from outer retinal degeneration.

The Iris system is comprised of a retinal implant and a pair of camera-mounted glasses connected to a “pocket computer.” The computer processes images captured by the glasses and transmits the data into a signal that’s transferred back and projected onto the intraocular implant, where it stimulates the optic nerve and generates images that the brain learns to interpret as visual signals.

“The progress in research with vision restoration of some visual perception is a reality, particularly with retinal prostheses. This research is addressing the growing patients’ expectations and their hope to regain some sight. On behalf of our member organisations, we are delighted to welcome the new bionic vision system IRIS II that may offer people suffering from retinitis pigmentosa a new treatment option with a design that is intended to be explantable and upgradeable,” Retina International prez Christina Fasser said in a press release.

The Iris II system is a 150-electrode epi-retinal implant designed to be upgradeable and explantable, and integrates continuous image capture with “time independent pixels” and 3 times the number of electrodes than its previous version, Pixium said.

“The CE mark certification is a major step forward for Pixium Vision and for retinal dystrophy patients who have lost their sight. This recognition, by an independent expert body, validates the long-term multidisciplinary work that has resulted in market approval of the IRIS II system. We will continue to develop our bionic vision systems with the aim to deliver improved visual perception and help retinal dystrophy patients lead more independent lives,” CEO Khalid Ishaque said in a prepared statement.

In May, Pixium said it won U.K. Medicines & Healthcare products Regulatory Agency approval to initiate a clinical trial of its Iris II bionic vision system.

In February, Pixium announced the 1st implantation and successful activation of its Iris II epi-retinal implant designed for patients with vision loss as a result of retinitis pigmentosa.

The 1st implant took place in January and was performed by Michel Weber of France’s University Hospital of Nantes, the company said. Up to 10 patients are slated to be included in a clinical trial of the device, according to Pixium Vision.

Filed Under: Optical/Ophthalmic, Regulatory/Compliance Tagged With: Pixium Vision

More recent news

  • FDA grants expanded clearance for Levita Magnetics surgical robot
  • FDA adds Gradient denervation tech to advisory program
  • Former Intuitive sales leader joins surgical robot maker Virtual Incision as CEO
  • Smith+Nephew to open first orthopedic ambulatory surgery center in the UK
  • Medtronic partners with IRCAD on Hugo, Affera surgical training

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy