Medical Devices: Page 7

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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
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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
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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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
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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
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    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
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    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
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    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
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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
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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
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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
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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
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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
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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
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    Getty Images
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    AI devices with no clinical validation tied to more recalls, study finds

    Public companies, which accounted for about half of AI-enabled devices on the market, had a higher rate of recalls and a lower rate of clinical evidence, according to a JAMA study.

    By • Sept. 2, 2025
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    Alamy
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    Medtech VC funding on track to hit highest value since 2021: PitchBook

    “Larger rounds increasingly favor top-tier companies and AI-native startups, leaving other startups fighting for a smaller pool of capital,” the firm said.

    By • Sept. 2, 2025
  • illustration of a heart showing a tube-shaped device going into the left ventricle
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    Courtesy of Abiomed
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    J&J removes some Abiomed heart pump controllers from market

    Abiomed reported one death associated with a pump driver circuit assembly that does not meet current specifications. The recall affects 69 controllers, a J&J spokesperson said.

    By • Aug. 28, 2025
  • A picture of Inspire Medical Systems' patient app and remote.
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    Courtesy of Inspire Medical Systems
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    Inspire CFO Rick Buchholz to step down at end of 2025

    RBC analysts said their views on the company are unchanged because the departing CFO will see the “Inspire V roll-out efforts through to completion.”

    By • Aug. 28, 2025