The Latest

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    Informa TechTarget

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    Note from the Editor-in-Chief

    A change in ownership and what it means for our readers.

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    Sarah Silbiger via Getty Images
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    FDA issues final guidance on postmarket updates to AI-enabled devices

    By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.

  • CMR Surgical Co-founder and CMO Mark Slack stands with his arms crossed in front of a Versius robot.
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    Permission granted by CMR Surgical
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    Q&A

    How CMR Surgical is taking on robotics’ ‘800-pound gorilla’

    “I don't think a monopoly market is healthy,” said CMR co-founder Mark Slack, discussing robotic surgery pioneer Intuitive Surgical’s continuing dominance in the market.

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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.

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    Courtesy of GE Healthcare
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    GE Healthcare to buy radiopharmaceutical firm Nihon Medi-Physics

    GE Healthcare has identified radiopharmaceuticals as a growth driver for the company and Japan as a key market.

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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.

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    Courtesy of GuardantHealth
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    Guardant awarded nearly $293M in false ad trial against Natera

    Natera allegedly made “false and misleading statements” to convince people to use its Signatera cancer test rather than Guardant’s rival product Reveal.

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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.

  • A large group of dosing pens for subcutaneous injection of anti-obesity medication piled in a heap.
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    aprott via Getty Images
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    Biden administration proposes Medicare, Medicaid coverage of pricey weight loss drugs

    About 7.4 million Americans with obesity could have insurance coverage for drugs like Wegovy if the Trump administration allows the rule to go into effect — at the cost of $40 billion to federal and state governments.

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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.

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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.”

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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.

  • 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.

    Updated Nov. 26, 2024
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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.

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    Noam Galai via Getty Images
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    Johns Hopkins surgeon Makary is Trump’s pick to lead FDA

    A prolific medical researcher and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.

    FDA
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic, Tempus testing AI to find potential TAVR patients

    The randomized trial will use Tempus’ platform to find patients who are eligible for interventions such as TAVR but do not have a treatment plan in place.

  • 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.

  • 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.