MassDevice

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

Home » Lumendi wins CE Mark, launches DiLumen EIP in EU

Lumendi wins CE Mark, launches DiLumen EIP in EU

By

Lumendi

Lumendi said today it launched its DiLumen endolumenal interventional platform endoscope sleeve after winning CE Mark approval in the European Union for the device.

The Buckinghamshire, U.K.-based company said its DiLumen EIP is a non-sterile, single-use sleeve designed to fit over standard endoscopes to stabilize the devices in the large intestine.

Lumendi touted that the device has already been used in more than 400 procedures, and has been the subject of three clinical studies, the results of which are slated to be published later this year.

“Receiving approval to apply the CE mark in Europe is critical to Lumendi’s overall global strategy to open markets around the world to continue improving endoscopic interventions and migrating many gastrointestinal surgeries to less invasive endolumenal procedures. To make the DiLumen EIP platform available across the EU, we are building a team to support our distributors in Europe in both marketing and clinical application,” CEO Dr. Peter Johann said in a prepared statement.

In May, Lumendi said it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures.

In case you missed it

RSS From Medical Design & Outsourcing

  • FDA approves Medtronic’s spinal cord stimulation for chronic pain from diabetic neuropathy
    Medtronic (NYSE:MDT) announced today the FDA approved its Intellis and Vanta neurostimulator for treating chronic pain. The approval covers the Intellis rechargeable neurostimulator and the Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy. Get the full story at our sister site, MassDevice. The post FDA approves Medtronic’s spinal cord stimulation […]
  • ‘Itty bitty’ falloposcope imaging device used inside fallopian tubes for the first time
    After years of development, University of Arizona researchers have captured their first images inside fallopian tubes with a new device that could be used to search for early signs of ovarian cancer. University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope, which has a diameter of only 0.8 mm. “It’s itty bitty,”… […]
  • Hantel appoints VP of business development
    Hantel recently announced that it appointed Ron Balogh as VP of business development. The Hayward, California-based medtech design and contract manufacturing company appointed Balogh on Jan. 3. He will be responsible for serving the company’s current clients and growing the company by improving communications and its presence within the industry. Get the full story on… […]
  • iRhythm plans silent AFib screening pilots, high-level hires and Zio Watch evaluations
    iRhythm Technologies (NSDQ:IRTC) has big plans for 2022 and its remote external electrocardiogram monitors as the medical device developer gears up for growth. President and CEO Quentin Blackford is looking to hire an international general manager among other roles in the coming months, he told Medical Design & Outsourcing after presenting at this month’s 2022… […]
  • Innophase announces next-gen low-power WiFi modules
    Innophase (San Diego) recently announced its next-generation Talaria Two INP1014 and INP1015 WiFi plus BLE5 modules. The new modules are 40% smaller than the previous INP1010 and INP1011 platforms. INP1014 and INP1015 can enable edge-of-network IoT devices, including medical wearables, that require low power consumption and a direct-to-cloud connection, according to the company. The platforms… […]
  • Plastics and medical devices: Changes for safety and cost
    The move toward polypropylene and polyethylene in medical devices requires new manufacturing and assembly solutions such as ultrasonic and laser welding. Didier Perret, Emerson Plastics are ubiquitous in medical applications thanks to their light weight, durability and flexibility, among other attributes. However, concern has been increasing in recent years about the possible negative effects of… […]
  • Medtronic’s recall of HawkOne system is Class I
    The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind. So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier… […]
  • January 2022 Issue: The pandemic tested Medtronic’s mettle
      The pandemic tested Medtronic’s mettle: Its CFO explains how How Abbott seeks to improve care, health inequities for people with cardiovascular disease Medtech’s biggest personnel changes in 2021 The top 5 medtech news stories of 2021 Some thoughts for medtech leaders in 2022 Starting our third year of the COVID-19 pandemic, I wonder when… […]
  • Feinstein Institutes researchers develop tiny implantable neurostimulator for mouse studies
    Researchers have developed a novel, fully implantable wireless bidirectional vagus nerve stimulation (VNS) and sensing device for mice. Engineers and researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research published details about the device and its capabilities in Biosensors and Bioelectronics. They think the device has the potential to transform how… […]
  • MIT team working on all-in-one diabetes management devices
    MIT researchers are touting a platform aimed at helping patients maintain healthy glucose levels by streamlining the diabetes management process. The MIT researchers say it’s hard for people with diabetes to maintain a treatment regimen. Typically at every meal, they need to estimate carbohydrate content, draw blood to measure blood glucose levels, and calculate the… […]
  • Element expands life sciences testing business with pharma, biotech capabilities
    Element Materials Technology recently announced that with the completed acquisition of JMI Laboratories in 2021, it has built out its life sciences testing capabilities for the pharmaceutical and biopharmaceutical industries. The acquisition added more than 1,000 experts in 23 facilities in North America and Europe and marked a strategic shift for the London-based company to… […]