Medical Devices

  • A person walks in a forest with a square device taped to their thigh.
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    Courtesy of Tandem Diabetes Care
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    Tandem recalls Mobi insulin pumps over software malfunction

    A malfunction may cause insulin delivery to stop. Tandem instructed users to update their pump software as soon as possible.

    By • April 22, 2026
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    Permission granted by AAMI
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    CDRH Director Tarver previews AI guidance at AAMI event

    Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial thoughts on generative AI following an advisory committee meeting last year.

    By • April 22, 2026
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendlineâž”
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • A modern office building with large reflective glass windows is shown behind a wide driveway and landscaped entrance. In the foreground, a white and orange monument sign reads "Intuitive Surgical" with the number "1020" vertically on the side.
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    Alamy
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    Intuitive Surgical lifts 2026 outlook for da Vinci robot procedure growth

    The company, whose shares climbed nearly 8% Wednesday morning, also said a recent cyber incident has been contained and did not significantly affect first-quarter results.

    By • April 22, 2026
  • Seven watches lined up side to side with different screens and colors.
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    Courtesy of Apple
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    Apple fends off Masimo challenge to Apple Watch redesign

    Apple can continue selling redesigned Apple Watches with a blood oxygen feature after the International Trade Commission concluded the products do not infringe Masimo patents.

    By • April 22, 2026
  • 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 leads $100M investment in Pulnovo Medical

    Medtronic formed a commercial agreement with Pulnovo alongside its investment.

    By • April 21, 2026
  • The CathWorks FFRangio System on a cart.
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    Permission granted by CathWorks
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    Medtronic closes $585M purchase of CathWorks

    The deal is the second tuck-in acquisition this year for Medtronic, which has signaled its intent to pursue more M&A in its core business lines.

    By • April 20, 2026
  • Two medical professionals in lab coats analyze brain scans on computer monitors while an MRI machine operates in the background.
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    iStock.com/gordoenkoff

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    Sponsored by Veeva MedTech

    LTS Lohmann builds a foundation for proactive quality and innovation

    How LTS Lohmann unified global quality data to eliminate silos and accelerate innovation.

    April 20, 2026
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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    Siemens plans shareholder vote on Siemens Healthineers spinoff

    The German parent, which is giving up its majority stake in Siemens Healthineers, said preparations for the transaction are progressing toward a vote at its February annual meeting.

    By • April 17, 2026
  • A person looks at a screen that shows an image of tissue with squares in yellow and red.
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    Permission granted by GE Healthcare
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    GE HealthCare, RadNet expand AI mammography collaboration

    The partnership adds access to a workflow for second reads of complex cases and other software features made by RadNet subsidiary DeepHealth.

    By • April 17, 2026
  • A concrete sign outside of a building reads "Department of Health & Human Services" wrapped around the HHS logo.
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    Kayla Bartkowski via Getty Images
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    CMS proposes repeal of add-on payment path for breakthrough devices

    The Centers for Medicare and Medicaid Services said it developed concerns about the limited evaluation process for the devices after gaining experience with the alternative pathway.

    By • April 17, 2026
  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
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    Courtesy of Exact Sciences
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    Abbott lowers earnings forecast after $21B Exact Sciences buy

    CEO Robert Ford said the companies are a good cultural fit and he expects demand for Exact’s colon cancer screening test to increase.

    By • April 16, 2026
  • A person in a suit touches a square device with a tube while two other people watch.
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    Courtesy of Boston Scientific
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    Boston Scientific plans $88.5M R&D expansion in Ireland

    The device maker plans to invest 75 million euros into expanding the site, with a focus on cardiovascular innovation.

    By • April 16, 2026
  • A modern two-story commercial office building with a mix of gray and wood paneling on the exterior. Large glass windows dominate both floors, and the front entrance features the "Medtronic" logo above double glass doors. The surrounding area includes a few small shrubs and empty parking spaces in front.
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    Alamy
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    Medtronic confirms paclitaxel balloon’s efficacy in post-approval trial

    The end-stage kidney disease device performed as well in the study as in a pivotal trial that supported FDA approval.

    By • April 16, 2026
  • A picture of Stereotaxis' GenesisX surgical robot against a white background.
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    Permission granted by Stereotaxis
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    Stereotaxis to buy Robocath for up to $45M

    The deal combines Stereotaxis’ magnetic navigation technology and Robocath’s mechanical robotic system, strengthening the company’s position in endovascular surgery, said CEO David Fischel.

    By • April 15, 2026
  • Office workstation top view of business people working around the letters "M&A" as well as a keyboard, calculator, phablet and money on wooden table.
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    Getty Images
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    AIP to acquire Avanos Medical in $1.27B go-private deal

    Avanos Medical generated $701.2 million last year from sectors where it competes with Boston Scientific, Medtronic and Stryker.

    By • April 15, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    Medline recalls angiographic syringes, receives FDA warning letter

    The company removed the devices from the market in February following complaints of the syringes disconnecting from manifolds.

    By • April 14, 2026
  • Medtronic's Stealth AXiS system.
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    Courtesy of Medtronic
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    GE HealthCare integrates ultrasound into Medtronic’s Stealth AXiS surgical system

    Partnering with GE HealthCare has enabled Medtronic to provide live images to help surgeons assess mid-procedure changes.

    By • April 13, 2026
  • A modern industrial building with beige and white walls and large blue-tinted glass windows. The name “Stryker” is mounted in black letters on the upper portion of the building. A white smokestack protrudes from the roof, and the sky is light and partly cloudy.
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    Alamy
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    Stryker to buy Amplitude Vascular Systems

    Amplitude’s intravascular lithotripsy technology could emerge as a challenger to Shockwave IVL, Leerink Partners analyst Mike Kratky wrote.

    By • April 13, 2026
  • Close-up of gloved hands handling a sealed medical package containing sterile equipment in a clinical setting.
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    iStock / Carmen Ruiz Alonso

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    Sponsored by PAXXUS

    The seal strength paradox: Why more is not always better in sterile barrier packaging

    What really determines seal performance in sterile packaging?

    April 13, 2026
  • Pulse Biosciences' pulsed field ablation tool is displayed against a white background.
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    Permission granted by Pulse Biosciences
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    Pulse Biosciences hires Liane Teplitsky as COO

    The appointment gives a former Abbott leader oversight of efforts to bring a pulsed field ablation device to market.

    By • April 10, 2026
  • A mechanical thrombectomy device is shown against a white background.
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    Courtesy of Endovascular Engineering
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    E2 raises $80M to market thrombectomy platform

    The funding round follows high-profile acquisitions by Boston Scientific and Stryker to pick up mechanical thrombectomy devices for blood clot removal.

    By • April 9, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA, medtech industry near MDUFA VI agreement

    The FDA said it intends to hire “substantial numbers” of medical device review staff as part of the agreement for the next medical device user fee amendments.

    By • April 9, 2026
  • A person sits in a chair in while another person attaches a blood pressure cuff on their arm. In the background is a wall with several framed photos.
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    John Moore via Getty Images
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    CDRH targets hospital readmissions with home device innovation challenge

    The center plans to pick nine devices to help support patients and caregivers after a hospital stay.

    By • April 9, 2026
  • A crowd watches the president sign an executive order in the Rose Garden of the White House.
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    Andrew Harnik / Staff via Getty Images
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    Deep Dive

    One year in: How medtech companies are coping with tariff challenges

    A resilient medtech industry navigating the fallout from President Donald Trump’s trade wars is taking proactive steps to manage tariff costs as the administration’s policies continue to evolve.

    By • April 9, 2026
  • Philips, Trilogy, evo, respirator
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    Courtesy of Philips
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    Philips warns not to use certain nebulizers in Trilogy Evo ventilator recall

    Using non-pneumatic nebulizers with the ventilators can lead to under-delivery of therapy to patients, the company said.

    By • Updated April 9, 2026