Labeling glitch with Boston Scientific’s Promus Element Plus prompts recall in Australia

From Medical Design & Outsourcing

• Google Health hires FDA’s chief digital health officer
  Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency. Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn. Patel recounted highlights of his “incredible journey since… […]
• Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
  Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection,… […]
• FDA moves forward with Voluntary Improvement Program to bolster medical device quality
  Kathryn Burke, Emergo Group The U.S. Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program. The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018.… […]
• How Minnetronix Medical helped Lazurite with its wireless surgical camera
  Minnetronix Medical (St. Paul, Minnesota) has played an important development and manufacturing partner role with Lazurite’s wireless surgical camera system. It’s been nearly two months since Lazurite (formerly Indago) announced FDA 510(k) clearance of its ArthroFree system. ArthroFree combines proprietary low-heat, high-intensity Meridiem light engine technology with advanced camera, battery and wireless transmission technologies and… […]
• Instron releases TrendTracker data analysis workflow platform
  Instron announced that it released the TrendTracker module in Bluehill Central for accelerating data analysis workflows. Norwood, Massachusetts-based Instron designed TrendTracker with an intuitive interface to improve the data analysis workflow of single or multi-location materials testing laboratories. According to a news release, the platform features quick searching and the ability to display and analyze… […]
• Henry Schein hires former Medline veteran to drive ‘One Distribution’ push
  Henry Schein (Nasdaq:HSIC) today named Dirk Benson as VP and chief commercial officer of the medical device manufacturer and distributor’s North America Distribution Group (NADG). Melville, New York-based Henry Schein is the world’s largest provider of health care supplies and services for office-based dental and medical practitioners, and NADG is the company’s largest business group. The… […]
• The road to a robot: Medtronic’s development process for its Hugo RAS system
  Elephants are the perfect analogy for surgical robotics, Medtronic (NYSE:MDT) VP of Marketing for Surgical Robotics Mike Stow says. Speaking on the “Road to a robot: Designing technology to address unmet needs & barriers” panel at DeviceTalks Boston last week, Stow explained that elephants are big, taking up a lot of space and that they eat a lot, making… […]
• iRhythm stays silent on federal grand jury subpoenas
  More than one year after receiving the first of two federal grand jury subpoenas seeking information about its products and communications with the FDA, iRhythm Technologies has said little publicly about the matter. It would have been easy to miss the San Francisco-based cardiac monitor maker’s initial disclosure last summer. iRhythm (Nasdaq:IRTC) was without a… […]
• How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
  A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor. The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions next month. The company also presented… […]
• Texas power grid struggles in heat one year after record cold stopped semiconductor plants
  A heatwave in Texas took at least six power plants offline Friday, with high temperatures forecasted to blaze throughout this week. A record cold snap in February 2021 took NXP Semiconductors and Samsung chip fabrication facilities offline for weeks, contributing to a global semicondcutor shortage that is still throttling medical device production. There’s no indication… […]
• How Stryker includes users for product design in the digital age
  Medical device developers and manufacturers like Stryker (NYSE:SYK) are changing how they approach design as digital technology becomes more crucial. Four Stryker executives shared how the Kalamazoo, Michigan–based orthopedic device giant is thinking differently about medical product development and how health care providers and patients will ultimately use them. The DeviceTalks Boston panel of Stryker… […]