Medical Devices: Page 9


  • Three rings, with silver, gold and copper tints.
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    Permission granted by Movano Health
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    Movano receives FDA nod for smart ring’s pulse oximeter feature

    Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.

    By Dec. 3, 2024
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    Permission granted by Johnson & Johnson
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    J&J appoints Shawn Millerick to lead vision care unit in the Americas

    Millerick, who spent time at Abbott and Alcon, is responsible for defining strategy and driving growth at a J&J business that sells products including Acuvue contact lenses.

    By Dec. 2, 2024
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Noam Galai via Getty Images
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    Advamed CEO stresses need for safety, efficacy after Trump picks Makary to lead FDA

    Martin Makary, a Johns Hopkins surgeon and researcher, has been critical of the FDA. He could have the most influence over device policy among Trump’s nominees.

    By Nov. 27, 2024
  • Professional photo of Dev Kurdikar
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    Permission granted by Embecta
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    Embecta discontinues insulin patch pump development

    CEO Dev Kurdikar said the decision may “come as a surprise” as Embecta just received FDA clearance for a patch pump, but the company “did not intend to do a full market launch of this product.”

    By Nov. 26, 2024
  • Donald Trump speaks at a campaign event in Reading, Pennsylvania.
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    Chip Somodevilla via Getty Images
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    Trump calls for 25% tariffs on imports from Canada and Mexico

    The president-elect also called for additional 10% tariffs on imports from China as part of his day one White House plans.

    By Philip Neuffer • Updated Nov. 26, 2024
  • The exterior of the Veterans Affairs Hospital in New York City.
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    Spencer Platt/Getty Images via Getty Images
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    Medtronic wins VA contract to install AI-powered endoscopy units

    The three-year contract expands Medtronic’s work with the VA to cover the installation of almost 100 more GI Genius endoscopy modules at U.S. centers.

    By Nov. 26, 2024
  • Xray of a man's knee
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    gorodenkoff via Getty Images
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    Zimmer wins FDA approval for cementless partial knee implant

    The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S.

    By Nov. 26, 2024
  • A person wearing gloves holds a round, metallic device in their palms.
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    Courtesy of Intera Oncology
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    Boston Scientific to buy Intera Oncology, maker of liver cancer treatment

    Intera makes a pump and a chemotherapy drug to treat liver tumors. Boston Scientific sees the purchase as a way to provide more comprehensive cancer treatments.

    By Nov. 25, 2024
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    gremlin via Getty Images
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    Sponsored by Altium

    From SpaceTech to MedTech: What medical device engineering teams can learn from aerospace

    High-stakes industries like aerospace and MedTech face similar challenges with outdated workflows. Streamlined, cloud-based systems are driving change.

    Nov. 25, 2024
  • A white, rectangular sticker device is in front of a blue, pen-shaped device.
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    Courtesy of Medtronic
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    Medtronic nets FDA nod for smart insulin pen app

    The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.

    By Nov. 22, 2024
  • Front sign of FDA building
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    Sarah Silbiger via Getty Images
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    FDA plan would alert public sooner on high-risk device recalls

    The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of potentially high-risk recalls and when the public is notified.

    By Nov. 22, 2024
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic buys surgical instrument developer Fortimedix

    Fortimedix develops flexible surgical instruments that are responsive enough to navigate the body and enable endoscopic and minimally invasive procedures.

    By Nov. 22, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Philips revises ventilator directions after airflow issue tied to 4 injuries

    Aerosol deposits could accumulate on a sensor and affect oxygen delivery, the FDA said in a recall notice. Several of the ventilator models were previously recalled for separate problems.

    By Nov. 21, 2024
  • Professional photo of Vicky Demas
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    Courtesy of Identifeye Health
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    Verily alum looks to improve access to retinal scans

    CEO Vicky Demas joined Identifeye Health, a startup building an AI-supported retinal imaging device, after stints with Google’s sibling Verily and Grail.

    By Nov. 21, 2024
  • President-elect Donald Trump, wearing a MAGA hat, and Dr. Oz shake hands as Oz exits a stage.
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    Win McNamee / Staff via Getty Images
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    Advamed CEO welcomes Dr. Oz as Trump’s pick to lead CMS

    Scott Whitaker said Mehmet Oz knows firsthand the impact of medical technologies on disease prevention and treatment. Oz holds a patent on Abbott’s Mitraclip heart device.

    By Nov. 20, 2024
  • Dr. Oz waves to campaign supporters
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    Win McNamee/Getty Images via Getty Images
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    Trump nominates Dr. Oz to oversee Medicare, Medicaid as CMS head

    On Truth Social, President-elect Donald Trump said Oz, who is best known for his eponymous TV show, would take on the “illness industrial complex.” 

    By Sydney Halleman • Nov. 20, 2024
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic’s ablation sales slowed by PFA supply issues

    CEO Geoff Martha said the business did not meet internal growth expectations last quarter due to third-party supply issues that have now been resolved.

    By Nov. 19, 2024
  • A picture of building with large glass windows and a parking lot, with flowers and grass in the foreground
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    Permission granted by Abbott
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    Abbott opens plant in Ireland to boost Libre 3 sensor production

    More than 800 people will be employed at the plant, which will make more Libre sensors than any of the company’s other facilities.

    By Nov. 19, 2024
  • A closeup of Boston Scientific's Watchman FLX device is shown against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific’s Watchman could be new option for patients post ablation: study

    The trial compared the stroke prevention device for left atrial appendage closure to blood thinners in people who underwent cardiac ablation for AFib.

    By Nov. 18, 2024
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    The PFA race is heating up. Here’s where the market stands after J&J’s approval.

    Boston Scientific, Medtronic and J&J are moving quickly to secure their place in the fast-growing pulsed field ablation space as new devices and heart imaging technology hit the market.

    By Nov. 18, 2024
  • A picture of Getinge's headquarters building in Gothenburg, Sweden.
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    Courtesy of Getinge
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    FDA warns providers on Getinge devices tied to 17 serious injuries

    Getinge recalled endoscopic vessel harvesting devices after receiving 18 complaints in four months. The FDA added the devices to its shortages list following the recall.

    By Nov. 18, 2024
  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Boston Scientific closes $3.7B Axonics deal after lengthy review

    Boston Scientific announced the acquisition in January, but the review dragged on after the Federal Trade Commission requested more information.

    By Nov. 15, 2024
  • Thermo Fisher Scientific
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    Courtesy of Thermo Fisher Scientific
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    Thermo Fisher eliminating 160 jobs, closing Massachusetts facility

    A facility in Lexington will close, and smaller numbers of people will be laid off at plants in Cambridge and Plainville.

    By Nov. 15, 2024
  • RFK Jr. shakes hands with Donald trump on stage with a crowd behind watching
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    Rebecca Noble via Getty Images
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    Trump nominates RFK Jr. to lead HHS

    The nomination of a prominent vaccine skeptic to the head of the nation’s largest healthcare program is expected to alarm some public health experts.

    By Sydney Halleman • Nov. 14, 2024
  • FDA headquarters sign
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    Stock via Getty Images
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    FDA breakthrough device decisions rebound after recent declines

    The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the downward trend seen as the COVID-19 pandemic eased.

    By Nov. 14, 2024