Medical Devices: Page 2


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    Elise Reuter/MedTech Dive
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    Troy Tazbaz, CDRH digital health leader, resigns

    Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.

    By Jan. 31, 2025
  • A picture of the surgeon's console for Intuitive Surgical's da Vinci 5 surgical robot.
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    Courtesy of Intuitive Surgical
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    2025 outlook

    Top medtech trends in 2025: New products and M&A are bright spots, but Trump brings uncertainty

    Experts highlighted surgical robotics, artificial intelligence and M&A as top trends this year. However, the Trump administration could create challenges for the industry.

    By Jan. 31, 2025
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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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    Retrieved from Nasdaq on January 31, 2025
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    Beta Bionics raises $204M in IPO

    The diabetes tech firm began trading this week and was valued at $966.2 million as of Thursday.

    By Jan. 31, 2025
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    Sarah Silbiger via Getty Images
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    FDA warns about patient monitor cybersecurity vulnerabilities

    Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the devices, the FDA warned.

    By Jan. 31, 2025
  • A picture of Getinge's headquarters building in Gothenburg, Sweden.
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    Courtesy of Getinge
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    Getinge exits surgical perfusion, creating opportunity for Livanova

    Getinge CEO Mattias Perjos said surgical perfusion has “been a struggling category” since an FDA consent decree forced the company off the U.S. market in 2015.

    By Jan. 30, 2025
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    Alex Wong via Getty Images
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    White House rescinds memo pausing federal funding following pushback

    The Office of Management and Budget rolled back a memo halting federal funding that caused widespread confusion and alarm. But “this is NOT a rescission of the federal funding freeze,” Trump’s top press secretary said.

    By Rebecca Pifer • Jan. 29, 2025
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    HadelProductions via Getty Images
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    Stryker to sell spinal implants business

    The company named a new CFO and shared an update on its planned Inari Medical acquisition.

    By Jan. 29, 2025
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    Courtesy of Intuitive
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    Deep Dive // 2025 outlook

    4 robotic surgery trends to watch in 2025

    Intuitive Surgical will face competition this year from Medtronic and smaller companies like CMR Surgical and Moon Surgical coming to the U.S. market with robotic surgery systems.

    By Jan. 29, 2025
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    Kayla Bartkowski/Getty Images via Getty Images
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    Lawmakers report states shut out of Medicaid payment portals following Trump funding freeze

    Other payment systems also appear to be offline, suggesting a broader shutdown of federal portals related to grants and funding.

    By Rebecca Pifer • Updated Jan. 28, 2025
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    Anna Moneymaker via Getty Images
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    Trump freezes federal grants with big potential impact on providers, Medicaid

    Federal agencies must stop disbursing financial assistance starting at 5 p.m. today under a new budget directive, threatening funding for providers and creating significant uncertainty for Medicaid payments to states.

    By Rebecca Pifer • Jan. 28, 2025
  • A red case with a picture of a heart and a lightning bolt and the word 'Philips' is on a plastic shelf fixed to a wall.
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    Courtesy of Philips
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    Philips to sell emergency care business

    Investment firm Bridgefield Capital will buy the segment, which includes cardiac resuscitation and emergency care devices, for an undisclosed amount.

    By Jan. 28, 2025
  • A picture of two people staring at the camera, one is leaning against a wall and one is sitting on a bench, in a white room.
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    Courtesy of Neko Health
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    Neko Health raises $260M to expand body scan service, fund R&D

    The company uses various medical devices to noninvasively check moles, the heart and more.

    By Jan. 28, 2025
  • FDA webpages on clinical trial diversity removed after Trump orders

    The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, a physician said.

    By Jan. 27, 2025
  • A picture of a blue pulsed field ablation catheter against a gray background.
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    Courtesy of Johnson & Johnson
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    Doctors expect Boston Scientific to lead PFA race, survey finds

    Physicians also expect greater use of Johnson & Johnson’s Varipulse system over the next two years despite the company’s current pause of U.S. cases, according to a poll by BTIG.

    By Jan. 27, 2025
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    Sarah Silbiger via Getty Images
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    Sara Brenner named acting FDA commissioner

    Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new leader is confirmed.

    By Jan. 24, 2025
  • A surgeon using a davinci intuitive robot
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    Courtesy of Intuitive
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    Trump tariffs

    Intuitive execs cast wary eye on potential Trump tariffs

    The surgical robot leader is watching developments under the new administration but has not included any tariff impact in its financial forecast.

    By Jan. 24, 2025
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    Courtesy of Medtronic
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    Medtronic links closed-loop pain device to improvements after 12 months

    The Inceptiv data give Medtronic more evidence as it tries to increase sales of a product that drove double-digit growth at the company’s pain stimulation unit last quarter.

    By Jan. 24, 2025
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    Rebecca Noble via Getty Images
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    Senate sets date to vet RFK Jr.’s nomination to lead HHS

    The Senate Finance Committee will meet on Jan. 29 to discuss the confirmation of RFK Jr., whose stances on vaccines and abortion have raised questions from Democrats and Republicans alike.  

    By Kristin Jensen • Jan. 23, 2025
  • A picture of the tower for Intuitive Surgical's da Vinci 5 robotic surgery system.
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    Courtesy of Intuitive Surgical
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    Intuitive inks deals to sell robots in Italy, Spain and Portugal

    Intuitive is buying businesses that distribute its da Vinci and Ion surgical robots to establish a direct presence in Italy, Spain, Portugal, Malta and San Marino.

    By Jan. 23, 2025
  • President Donald Trump addresses the press at the White House on Jan. 21, 2025.
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    Andrew Harnik via Getty Images
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    Trump eyes 10% China tariff hike by Feb. 1

    The president floated a similar timeline for 25% tariffs on Canada and Mexico.

    By Philip Neuffer • Jan. 23, 2025
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    Permission granted by Abbott
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    Abbott expects to launch first PFA device outside of the US this year

    CEO Robert Ford also plans to expand sales of the company’s Lingo over-the-counter glucose sensors after a limited rollout.

    By Jan. 22, 2025
  • New Masimo CEO Katie Szyman wears a navy blue jacket and white shirt.
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    Permission granted by Masimo
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    Masimo picks Katie Szyman as CEO

    Szyman led Edwards Lifesciences’ critical care unit for more than a decade before BD acquired the group last year. Her appointment “fits like a glove,” BTIG analyst Marie Thibault wrote.

    By Jan. 22, 2025
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    Retrieved from Mass General Brigham on January 22, 2025
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    Deep Dive // 2025 outlook

    AI in medtech is taking off. Here are 4 trends to watch in 2025.

    New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

    By Jan. 22, 2025
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific study meets goals for PFA in persistent AFib

    The results will support the company’s application for expanded labeling of its popular Farapulse pulsed field ablation system in a larger group of patients with atrial fibrillation.

    By Jan. 21, 2025
  • Professional photo of Thierry Piéton
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    Permission granted by Medtronic
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    Medtronic names Thierry Piéton as CFO

    Piéton fills an opening left by Karen Parkhill, who became HP’s CFO in August after eight years with Medtronic.

    By Jan. 21, 2025