Medical Devices

  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA warns on unauthorized blood pressure, infant monitoring devices

     Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.

    By • Sept. 17, 2025
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
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    Courtesy of Siemens Healthineers
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    Stryker, Siemens Healthineers partner on neurovascular robot

    The companies will develop a robotic system to improve patient outcomes in complex hemorrhagic cases and time-sensitive ischemic strokes.

    By • Sept. 17, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
  • Becton Dickinson logo
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    BD expands Class I recall to cover 15 more Alaris pump infusion sets

    BD, which has not received any complaints related to the issue, previously discontinued the devices affected by the expanded recall.

    By • Sept. 17, 2025
  • Professional photo of Flavia Pease
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    Retrieved from Insulet on September 16, 2025
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    Insulet names new CFO; Dexcom CEO on leave

    Flavia Pease will take over as Insulet’s CFO on Sept. 30. Elsewhere, outgoing Dexcom CEO Kevin Sayer is taking a medical leave of absence.

    By • Sept. 16, 2025
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    Courtesy of Aidoc
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    Deep Dive

    How three companies are using foundation models in radiology

    Some firms, such as Aidoc, are working directly with the FDA. Others, such as HOPPR, are offering their foundation models for medtech companies to build their own AI tools. 

    By • Sept. 16, 2025
  • A person wearing a shirt that says "Mosaic" stands and speaks in front of two computer screens showing text and images.
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    Permission granted by Radiology Partners
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    Deep Dive

    Foundation models are medtech’s newest trend. But what are they?

    The AI models, which are built on massive datasets and can be adapted to multiple tasks, have become a part of medtech companies’ lexicon in the past few years.

    By • Sept. 15, 2025
  • A surgeon sits at the console of a da Vinci 5 robot while another medical professional works in the background.
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    Courtesy of Intuitive Surgical
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    Intuitive da Vinci 5 updates offer feedback during surgery

    Three new software features for Intuitive’s most advanced soft tissue surgical robot have received 510(k) clearance from the Food and Drug Administration.

    By • Sept. 15, 2025
  • Surgeon and Nurses at Surgery Room
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    Ugur Karakoc via Getty Images
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    B. Braun buys True Digital Surgery for microscopy technology

    The acquisition gives B. Braun control of a company that provides technology for its Aeos robotic digital microscope.

    By • Sept. 15, 2025
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    Courtesy of Aidoc
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    AI drives medtech investment in 2025

    Medical device companies working with artificial intelligence raised funding and were acquisition targets in recent months.

    By • Sept. 12, 2025
  • A picture of Masimo's headquarters building.
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    Mario Tama / Staff via Getty Images
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    Masimo, Philips extend patient monitoring partnership

    The multi-year agreement comes two months after Philips renewed a partnership for patient monitoring technologies with Masimo competitor Medtronic.

    By • Sept. 11, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    hapabapa via Getty Images
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    Patients call for more medical device user fee funding, FDA staffing

    Commenters to the FDA also advocated for safety reforms and for industry funds to be used for post-market monitoring.

    By • Sept. 11, 2025
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    Patrik Stollarz / Staff via Getty Images
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    Philips under investigation by Paris Prosecutor’s Office over recalled respiratory devices

    The prosecutor’s office opened an investigation in June, with charges including aggravated fraud and failure to report incidents that pose serious health risks.

    By • Sept. 10, 2025
  • A commercial building displays a “Boston Scientific” sign on its exterior. The structure features a smooth white facade with reflective windows and minimal architectural detailing, set against a partly cloudy sky.
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    Alamy
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    Boston Scientific inks $88M Elutia deal to challenge Medtronic

    BTIG analysts estimate that Elutia’s Elupro and Medtronic’s TYRX are competing for a $600 million opportunity in the U.S. cardiac rhythm management sector.

    By • Updated Sept. 11, 2025
  • 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 wins IDE approval; Galvanize pulls in $100M

    Pulse Biosciences will study PFA in cardiac surgery. Meanwhile, Galvanize Therapeutics also named a new CEO, and PFA pioneer Steven Mickelsen has launched another company.

    By • Sept. 9, 2025
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    Sarah Silbiger via Getty Images
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    Microbot receives 510(k) clearance for endovascular robot

    The company will now complete final commercial activities in preparation for targeting the 2.5 million peripheral vascular procedures performed in the U.S. each year.

    By • Sept. 9, 2025
  • Three clinicians in blue scrubs are shown operating Ronovo Surgical's Carina robotic system.
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    Courtesy of Ronovo Surgical
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    Ronovo Surgical raises $67M, led by J&J venture arm

    Ronovo, a Chinese surgical robotics company, will also team with a J&J subsidiary in Shanghai to sell Ronovo’s soft tissue platform and complementary J&J technologies.

    By • Sept. 8, 2025
  • A black reader is shown on top of a phone with a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics inks deal to bring CGM commercialization back in-house

    BTIG analysts said Senseonics is doubling down on its belief an inflection point in patient demand is imminent, but the company will need a large sales force to win market share.

    By • Sept. 8, 2025
  • Professional photo of Erez Kaminski
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    Permission granted by Ketryx
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    AI firm Ketryx raises $39M, adds former Medtronic CEO as investor

    The company, which helps medtech companies with AI compliance, has raised more than $55 million to date.

    By • Sept. 5, 2025
  • Four medtronic Hugo surgical robots
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    Courtesy of Medtronic
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    Medtronic trial of Hugo robot in hernia repair hits primary endpoints

    The company reported a 100% surgical success rate, beating the pre-specified 85% performance goal to meet the trial’s primary effectiveness endpoint.

    By • Sept. 5, 2025
  • Modern office building with tall glass windows and palm trees lining the entry drive. A large white and green sign in the foreground reads “Dexcom” with the number “6350” below. Surrounding the sign are colorful landscaping features including small bushes, flowers, and a mulched bed. Cars and flags are visible in the background.
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    Alamy
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    Dexcom to lay off about 350 people

    The diabetes technology company said the cuts are part of broader changes to its structure, including eliminating operations roles in San Diego and shifting those positions to Arizona.

    By • Sept. 4, 2025
  • A coil-shaped device is shown moving through a tube with branching structures around it.
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    Courtesy of Medtronic
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    Renal denervation gets strong backing from cardiologists ahead of Medicare coverage decision

    Doctors told the Centers for Medicare and Medicaid Services that more patients need access to the procedure, with one calling it the start of a new era in hypertension management.

    By • Sept. 4, 2025
  • Kardium's Globe mapping and ablation catheter for pulsed field ablation is shown.
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    Courtesy of Kardium
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    Kardium receives FDA OK for pulsed field ablation system

    The company raised $250 million in July to expand its manufacturing capabilities and establish multiple teams to support the launch.

    By • Sept. 4, 2025
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    3 medtech takeaways from ESC 2025

    Pulsed field ablation and transcatheter aortic valve implants were in focus at the European Society of Cardiology Congress in Madrid.

    By • Sept. 3, 2025
  • Edwards Lifesciences' Sapien 3 Ultra heart valve replacement system is shown with the valve expanded by a balloon.
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    Courtesy of Edwards Lifesciences
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    Edwards, Medtronic and Abbott stand to benefit from new TAVR guidelines in Europe

    Analysts said the companies should benefit “as the therapy algorithm is further streamlined and additional patients are encouraged to receive TAVR.”

    By • Sept. 3, 2025
  • A person stands outside wearing a small, square device with a cord on their belt.
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    Permission granted by Medtronic
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    Medtronic advances Abbott partnership with FDA nod

    The company received FDA authorization to pair its 780G insulin pump with a glucose sensor made by Abbott, and to use the device for Type 2 diabetes.

    By • Sept. 2, 2025