FSS lands extended CE Mark for FlexStent | Regulatory Roundup

From Medical Design & Outsourcing

• Medtronic CFO offers supply chain update as medical device industry concerns mount
  Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips. Still, CFO Karen Parkhill says the world’s largest medical device manufacturer is not in the same dire straits as chip buyers in other industries. Medtronic’s supply chain is “holding up OK, but… […]
• SeaSpine warns of COVID-19 hit to surgical revenue
  SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business. Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Friday, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes throughout… […]
• Women may have more adverse events with left atrial appendage occlusion devices than men
  Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today. In a letter to health care providers, the FDA said researchers have yet to determine the reason for the difference — and that it is working with device makers to… […]
• A closer look at a microrobot that could treat a rare brain malformation
  Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers. The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation. In 1914, neurosurgeon Walter… […]
• Heraeus buys Mo-Sci and ETS Technology Holdings
  The Heraeus Group has a deal to acquire Mo-Sci Corp. and ETS Technology Holdings, the Germany-based conglomerate announced this week. Mo-Sci is a supplier of glass microspheres, fibers and powders for medical devices, while ETS is the developer of bioactive glass fiber wound care product Mirragen, an FDA-cleared resorbable synthetic skin substitute. The companies —… […]
• Medical Alley appoints new CEO
  The Medical Alley Association announced today that it appointed Roberta Dressen as its new president and CEO. Dressen takes over the position previously held by Shaye Mandle since 2014 before he announced his departure for the Biotechnology Innovation Organization (BIO) in February. Steffen Hovard served as interim CEO in the time since then. Get the full… […]
• Westfall Technik names Mark Gomulka as CEO
  Westfall Technik’s board of directors has nominated Mark Gomulka to lead the company. Gomulka joined the Las Vegas–based plastics manufacturer as SVP in January 2020. Before that, he led Flex’s medical and precision plastics operations for five years and earlier spent 15 years at Nypro in various global operational and leadership roles. In those positions… […]
• 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
  Microrobotics startup Bionaut Labs has announced that FDA has granted a humanitarian use device designation for the device known as BNL-201 to treat 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 are currently… […]
• 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… […]