MassDevice

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

Home » GI Dynamics wins CE Mark for EndoBarrier

GI Dynamics wins CE Mark for EndoBarrier

By

GI Dynamics won CE Mark approval for its EndoBarrier gut liner and said it plans to launch the product across the pond during the first half of 2010.

The Lexington, Mass.-based company developed the EndoBarrier, a plastic sleeve that lines the small intestine, to treat obesity and Type 2 diabetes. The device prevents food from being absorbed by the body, inducing weight loss and helping control the symptoms of diabetes.

A series of clinical studies showed that patients treated with the EndoBarrier reduced their average blood glucose levels, lowered other diabetic factors including fasting blood glucose and weight and helped morbidly obese patients lose significant amounts of weight.

GI Dynamics said the CE Mark cover six months of EndoBarrier treatment for patients with Type 2 diabetes and obesity.

In case you missed it

RSS From Medical Design & Outsourcing

  • B. Braun receives FDA approval for Florida pharmaceutical manufacturing plant
    B. Braun Medical announced today that it received final approval from the FDA for its new pharmaceutical manufacturing plant. Bethlehem, Pennsylvania-based B. Braun’s Daytona Beach, Florida-based plant will produce 0.9% sodium chloride for injection available in B. Braun’s Excel Plus IV bags in 1,000 mL and 500 mL sizes. Get the full story at our… […]
  • 3D Printing: Making products better, faster, and more affordable
    With help from HP’s Multi Jet Fusion 3D printing technology, Biotec produces improved parts for its medical devices in less time and at a lower cost. Download this white paper… The post 3D Printing: Making products better, faster, and more affordable appeared first on Medical Design and Outsourcing.
  • Eli Lilly to build $1B manufacturing facility for injectable products, devices in North Carolina
    Eli Lilly (NYSE:LLY) announced today that it plans to invest more than $1 billion to create a new manufacturing site in North Carolina. Indianapolis-based Eli Lilly’s new facility, which it expects to bring with it nearly 600 jobs in Concord, North Carolina, will manufacture parenteral (injectable) products and devices while increasing the company’s manufacturing capacity. Get… […]
  • How Bigfoot Biomedical plans to take diabetes management forward
    For close to 20 years, Jeffrey Brewer has focused on finding ways to support insulin delivery and manage diabetes. Bryan Mazlish was the first person in the world to hack into an insulin pump and continuous glucose monitor (CGM) and enable a do-it-yourself closed-loop insulin dosing system, Brewer told Drug Delivery Business News. “It turned… […]
  • Edwards Lifesciences misses on Q4 earnings as omicron hammers hospitals
    Edwards Lifesciences (NYSE:EW) posted fourth-quarter results that fell short of the consensus forecast on Wall Street, but reaffirmed its outlook for 2022. The Irvine, California-based heart device company yesterday evening reported profits of $335.3 million — or $0.53 per diluted share — on sales of $1.33 billion for the three months ended Dec. 31, 2021,… […]
  • How Phillips-Medisize helped Sotech Health develop a breath analyzer for COVID-19
    Medtech contract manufacturing giant Phillips-Medisize used its human-factors product design expertise to help startup Sotech Health create what the companies claim is a breath sensor system that can detect COVID-19 in less than 30 seconds. Dallas-based Sotech Health has submitted the device to the FDA for an emergency use authorization. It’s also seeking regulatory nods… […]
  • Carbon introduces next-gen 3D printers
    Carbon today announced its next-gen M-Series 3D printers based on DLS technology. The new M3 and the M3 Max printers boast faster printing, a more straightforward print experience, expanded design space and a more consistent surface finish, according to Carbon. Carbon said a 4K light engine enables a doubling of the build area with the… […]
  • Philips launches at-home, 12-lead ECG for clinical trials
    Royal Philips (NYSE: PHG, AEX: PHIA) announced today that it is expanding its remote cardiac monitoring portfolio with a patch-based, clinical-grade ECG. The new at-home electrocardiogram monitors could reduce the need for site visits during clinical trials, according to the Dutch medtech giant. At-home ECG is a hot space: iRhythm Technologies CEO Quentin Blackford recently… […]
  • TE Connectivity beats the Street in Q1
    TE Connectivity (NYSE:TEL) posted first-quarter results today that beat the consensus forecast on Wall Street. The Schaffhausen, Switzerland–based company provides connectivity and sensor solutions for a broad range of industries, including medtech. The company reported profits of $566 million — or $1.72 per share — on sales of $3.8 billion for the fiscal quarter ended… […]
  • Element Materials Technology acquired by Temasek
    Element Materials Technology this week announced that it was acquired by Bridgepoint’s Temasek for an undisclosed amount. Singapore-based Temasek has been a majority shareholder in Element since 2019. Element expects to accelerate its growth and build stronger positions in end-markets like life sciences and connected technologies, according to the company. “The acquisition of Element by… […]
  • 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 […]

Leave a Reply