The Latest

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    Tim Boyle via Getty Images
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    Baxter closes dialysis solutions facility due to Hurricane Helene damage

    More than 2,500 people work at the facility, which is Baxter’s largest manufacturing site. The company is still working to fully assess the damage.

    Updated Sept. 30, 2024
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    Sarah Silbiger via Getty Images
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    Establishment Labs wins FDA approval for Motiva breast implants

    Motiva is the first new breast implant to receive premarket approval since 2013, according to Establishment Labs, and enters a market reshaped by safety issues linked to other products.

  • A picture of Masimo's headquarters building.
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    Mario Tama / Staff via Getty Images
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    What’s next at Masimo after CEO Kiani’s exit?

    Investors are waiting to learn the next steps for the patient monitoring company after a hard-fought proxy battle, including how a separation of its consumer business could play out.

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    Nuthawut Somsuk via Getty Images
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    Mendaera raises $73M to develop handheld robotics platform

    Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.

  • Jeff Shuren stands in front of a podium.
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    Permission granted by Peyton Helbert / AAMI
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    Lawmakers call for investigation of former FDA device director

    The letter to the health department watchdog follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.

  • Woman using a laptop to contact a medical professional about her health. She is siting at a table in a kitchen and is taking her blood pressure with a blood pressure gauge.
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    SolStock via Getty Images
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    Remote patient monitoring in Medicare needs more oversight: OIG

    Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.

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    Tom Brenner via Getty Images
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    Congress again delays steep cuts in Medicare lab payments

    The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.

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    AnkiHoglund via Getty Images
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    Medtech’s top executive moves in 2024

    Recent executive changes include former Medtronic CFO Karen Parkhill leaving for HP and Masimo CEO Joe Kiani resigning. Check out MedTech Dive’s roundup of leadership movement in 2024.

    Updated Sept. 26, 2024
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA proposes reclassifying hepatitis B assays

    The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

  • A person dressed in business attire sits in a white chair against a black background. IWhite glowing letters behind the chair read, "colli..."
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    The image by Ramsey Cardy/Collision/Sportsfile is licensed under CC BY 2.0
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    Masimo CEO, founder Kiani resigns

    Michelle Brennan was named acting CEO of the patient monitoring company following Joe Kiani’s defeat in a proxy battle with an activist investor.

  • A person lays with their arm outstretched and an x-ray camera facing it.
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    Courtesy of Siemens Healthineers
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    Medtronic, Siemens Healthineers partner on spine surgery

    Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite.

  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche launches test that detects 12 respiratory viruses

    Roche’s TAGS technology allows tests to simultaneously detect multiple respiratory viruses, including influenza A and B, RSV and the COVID-19 virus.

  • Ross Segan is shown in a headshot.
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    Permission granted by FDA
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    FDA names new head of medical device evaluation and quality

    Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

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    magicmine via Getty Images
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    Recalled heart devices had limited clinical testing, study finds

    Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

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    libre de droit via Getty Images
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    Route 92 Medical raises $50M to fund global sales of stroke devices

    The latest investment extends an earlier funding round, bringing the total raised to $82 million. Novo Holdings, the controlling shareholder of Novo Nordisk, joined returning investors.

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    Scott Olson/Getty Images via Getty Images
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    Deep Dive

    4 steps to minimize the threat of legacy medical devices

    Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

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    Getty Images via Getty Images
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    Stryker adds devices to remove brain tumors, clots with Nico buy

    Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue.

  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA posts draft guidance on biocompatibility testing of devices

    To promote consistency and reliability in premarket submissions, the FDA shared approaches for device biocompatibility analysis.

  • Masimo CEO Joe Kiani stands before an audience at a January 2024 meeting of the Patient Safety Movement Foundation.
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    Courtesy of Patient Safety Movement Foundation
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    Masimo investor claims proxy war win as CEO Kiani fails to retain board seat

    Politan Capital Management said its candidates captured two board seats in Thursday’s shareholder vote, citing a preliminary analysis.