Medtronic lands Canadian win for epilepsy therapy with brain stim | Regulatory Roundup

From Medical Design & Outsourcing

• The MedTech Conference by AdvaMed to be a mixture of in-person and virtual
  To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week. The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a… […]
• Varta launches online battery monitoring feature
  Battery maker Varta has launched a cloud computing feature to let customers remotely monitor battery charging, health and the temperature of the battery management system. While Varta makes microbatteries for medical devices such as hearing aids, the new online monitoring dashboard is meant for its “Easy Block” and “Easy Blade” modular smart batteries. The smart… […]
• Bionaut Labs wins humanitarian use device designation to treat rare pediatric brain disorder
  The microrobotics startup Bionaut Labs has announced that FDA has granted a humanitarian use device designation for the device known as BNL-201 to treat a Dandy-Walker syndrome, a congenital brain malformation affecting the cerebellum. According to the National Organization for Rare Disorders, the syndrome affects one out of every 25,000 to 35,000 live births. There… […]
• Integer plans $30 million innovation and manufacturing facility in Galway
  Integer Holdings Corp. (NYSE: ITGR) plans to build a medical device innovation and manufacturing facility in the Parkmore East area of Galway, Ireland. Plano, Texas–based Integer said the initial phase of the project will total 60,000 square feet and a $30 million investment over the coming years, with construction scheduled from 2022 to late 2023… […]
• Accu-Tube appoints Matthew Haddle as CEO
  Accu-Tube today announced that it has appointed Matthew Haddle as its new CEO. Prior to joining the Englewood, Colorado-based company, Haddle was GM of industrial coating services and equipment at Praxair Surface Technology. He has also held senior management positions at Albany Engineered Composites and Accellent. Get the full story on our sister site, Medical… […]
• LightDeck picks GS Plastic Optics for COVID-19 test ramp up
  LightDeck Diagnostics has selected GS Plastic Optics to make optical components for its new COVID-19 antibody testing platform. Boulder, Colorado–based LightDeck developed a screening platform to deliver results as quickly as five minutes for SARS-CoV-2 ultra-rapid antigen and COVID-19 total antibody tests, using a laser waveguide with a consumable cartridge for each testing sample.  Rochester,… […]
• Hologic’s first Global Women’s Health Index flags preventative care for improvement
  An estimated 1.5 billion women have not been tested in the past year for critical diseases, according to Hologic’s first Global Women’s Health Index. On behalf of diagnostic maker Hologic, the Gallup World Poll surveyed more than 60,000 women and girls (age 15 and older) across the world to measure action and attitudes about women’s… […]
• Medicine-saving Nanodropper makes history in Minnesota Cup win
  The Minnesota Cup has awarded its grand prize for innovative entrepreneurs to a student-led startup for the first time. Medical device developer Nanodropper took home top honors from the awards ceremony, held yesterday at the University of Minnesota. “We have created an eyedrop bottle adaptor that will save billions in medication waste, one drop at… […]
• Medtronic’s Hugo team ‘waiting for the phone call’ for approval in Europe
  It sounds like European approval of Medtronic’s soft tissue robotically-assisted surgery system, Hugo, could come any day now. “We’re sitting at the tip of our chair waiting for the phone call that the product will be approved,” Medtronic EVP and EMEA President Rob ten Hoedt said Friday. Fridley, Minnesota-based Medtronic (NYSE:MDT) filed for European approval… […]
• Ivy Brain Tumor Center sees promise in sonodynamic therapy for glioblastoma
  Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients. Sonalasense has developed a sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive. Data from the trial indicate that SDT swiftly causes targeted… […]
• Former Theranos scientist testifies to blood test inaccuracies prior to Walgreens deal in Elizabeth Holmes trial
  A former Theranos scientist testified on the inaccuracies of the company’s device during Elizabeth Holmes’ federal fraud trial. Surekha Gangakhedhar worked at Theranos from 2005 to 2013 and reported directly to Holmes at one point. She testified on Friday that Holmes allegedly pressured her to validate blood test results to speed up a rollout of… […]