Medical Devices


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    Courtesy of EOFlow
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    Insulet awarded $452M in EOFlow patent fight

    A jury found that competitor EOFlow and former executives misappropriated trade secrets for Insulet’s Omnipod insulin pumps.

    By Dec. 5, 2024
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    Courtesy of Edwards Lifesciences
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    Edwards expects new TAVR approval in mid-2025 to boost sales

    U.S. approval of an expanded indication for transcatheter aortic valve replacement in patients without symptoms is among the growth catalysts Edwards outlined in an investor day presentation.

    By Dec. 5, 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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    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.

    By Dec. 4, 2024
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    Haemonetics to offload whole-blood business for up to $67M

    Selling the assets to Italy’s GVS should help Haemonetics improve its revenue growth and profit margins, analysts said.

    By Dec. 4, 2024
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    Transmedics appoints Gerardo Hernandez as CFO effective immediately

    Hernandez started this week but his predecessor, Stephen Gordon, will continue as a non-executive employee until the end of March and serve as a senior adviser for one year after.

    By Dec. 4, 2024
  • 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.

    By Dec. 3, 2024
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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.

    By Dec. 3, 2024
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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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    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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    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
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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
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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
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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
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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
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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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    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
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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
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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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    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
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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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    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
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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
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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