Medical Devices: Page 5

  • 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
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendlineâž”
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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
  • 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
  • An embpty bed is surrounded by monitors and hospital equipment.
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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
  • A stack of US one hundred dollar bills is spread out on a table.
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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
  • 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 to lay off 331 employees in California

    The robotic surgery company, which filed a WARN notice with the state in August, plans for the layoffs to be effective in late October.

    By • Updated Aug. 28, 2025
  • Professional photo of Eric Benjamin
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    Permission granted by Insulet
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    Insulet promotes Eric Benjamin to chief operating officer

    As new CEO Ashley McEvoy works to build the brand globally, the diabetes tech company also hired Manoj Raghunandanan as chief growth officer.

    By • Aug. 26, 2025
  • Surgeons wearing scrubs monitor the OrganOx Metra organ preservation system.
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    Permission granted by BGF
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    Terumo to buy OrganOx for $1.5B to enter transplant field

    OrganOx could capture a greater share of the liver transplant market, where it competes with TransMedics Group, Needham analyst Mike Matson wrote.

    By • Aug. 25, 2025
  • Intuitive Surgical CEO Gary Guthart
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    Permission granted by Intuitive Surgical
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    Medtech firms shuffle execs in 2025

    Top leaders at Intuitive, Boston Scientific, Dexcom and others changed roles this year. Read MedTech Dive’s roundup for all the details.

    By • Aug. 25, 2025
  • Scene at a hospital waste management
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    Adobe/ Spyrakot

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    Sponsored by PAXXUS

    Sustainable medical device packaging solutions: Mono-materials that perform

    Mono-material packaging meets tough healthcare demands while improving recyclability.

    Aug. 25, 2025
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific recalls carotid stents over manufacturing defect

    The FDA said the defect could injure blood vessels, damage the stent or release debris that could travel to the brain and cause a stroke.

    By • Aug. 25, 2025
  • A procedure is performed in an operating room using CMR Surgical's Versius robotic system.
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    Courtesy of CMR Surgical
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    The robotic surgery market battle is heating up

    After a busy summer of surgical robotics news, check out MedTech Dive’s roundup of coverage in the space.

    By • Aug. 22, 2025
  • U.S. President Donald Trump speaks during a joint press conference with European Commission President Ursula von der Leyen on July 27, 2025, in Turnberry, Scotland.
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    Andrew Harnik via Getty Images
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    MedTech Europe sounds alarm over impact of US-EU tariffs on patients

    The trade group wants the U.S. to eliminate tariffs on medical technologies, warning that “patients cannot be collateral damage in trade tensions.”

    By • Aug. 22, 2025
  • FDA
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    Sarah Silbiger via Getty Images
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    More than 1,100 devices have received the FDA’s breakthrough designation

    The FDA updated its list of breakthrough devices as medtech groups lobby for faster Medicare coverage of products with the designation.

    By • Aug. 21, 2025
  • U.S. President Donald Trump speaks during a joint press conference with European Commission President Ursula von der Leyen on July 27, 2025, in Turnberry, Scotland.
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    Andrew Harnik via Getty Images
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    US, EU agree to terms of framework trade pact

    The two trading partners documented provisions of a deal that would set a 15% tariff on many EU imports, including cars, auto parts, pharmaceuticals and semiconductors.

    By Philip Neuffer • Aug. 21, 2025
  • Dr. Mehmet Oz sits on a table in front of a namecard bearing his name.
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    Anna Moneymaker/Getty Images via Getty Images
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    AdvaMed urges Dr. Oz to speed Medicare coverage of breakthrough devices

    The medtech trade group wants the CMS to take “bold action” to cut the lag between FDA authorization of devices and Medicare coverage.

    By • Aug. 21, 2025
  • A person wearing a black wristband holds a phone that says "103/65"
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    Permission granted by Aktiia
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    Q&A

    How Aktiia built the first over-the-counter cuffless blood pressure monitor

    Aktiia received FDA clearance in July for the first cuffless blood pressure monitor authorized to be sold over the counter.

    By • Aug. 20, 2025
  • NeuroOne
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    Permission granted by NeuroOne
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    NeuroOne gains FDA clearance for trigeminal nerve ablation

    The minimally invasive system uses radiofrequency energy to target nerve tissue causing facial pain.

    By • Aug. 20, 2025
  • CMR Surgical's Chris O'Hara poses in a dark blue suit and tie.
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    Courtesy of CMR Surgical
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    CMR Surgical hires Chris O’Hara to drive US robot expansion

    O’Hara joins CMR’s executive team as commercial president and general manager for the U.S., following the FDA’s authorization last fall for its Versius system.

    By • Aug. 19, 2025
  • 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 recall of heart vent catheters tied to 3 serious injuries

    The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being bent.”

    By • Aug. 19, 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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    Heart devices pace medtech’s summer funding flows

    July and August have brought a steady beat of private financings for young medtech companies, with several deals supporting new technologies to treat heart conditions.

    By • Aug. 18, 2025
  • Two people talk while a screen displays a medical image.
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    Courtesy of Philips
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    Philips will spend $150M to expand manufacturing for AI-enabled tech

    The investment includes increasing manufacturing and research and development capabilities at its Reedsville, Pennsylvania, facility.

    By • Aug. 15, 2025