Cardiac

  • Close up of a white cylindrical device.
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    Courtesy of Edwards Lifesciences
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    Edwards receives FDA approval for mitral valve replacement system

    The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

    By • Dec. 23, 2025
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    Sarah Silbiger via Getty Images
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    FDA posts Class I recall notice about Medtronic heart vent catheters

    The company received three complaints about patients who had perforation injuries linked to the devices.

    By • Dec. 23, 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
  • A picture of a medical catheter against a white background.
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    Courtesy of Abbott
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    Abbott receives FDA approval for Volt PFA system

    Abbott can now compete with Medtronic, Boston Scientific and J&J in the U.S. for the fast-growing pulsed field ablation market.

    By • Dec. 22, 2025
  • Modern glass and metal office building with a reflective blue-tinted facade, set against a clear blue sky. In the foreground, a large black and white sign reads “Abbott” with the company’s stylized logo and the number “645.” The area has neatly cut grass and a few small trees.
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    Alamy
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    Abbott receives clearance for heart delivery device in premature babies

    Physician feedback has informed a delivery device designed to make procedures safer and easier.

    By • Dec. 22, 2025
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    Getty Images
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    Pulse Biosciences wins FDA approval to begin PFA catheter study

    Shorter, nanosecond pulses for treating atrial fibrillation differentiate the company’s approach from existing pulsed field ablation systems on the market.

    By • Dec. 18, 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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    CMS considers expanding TAVR coverage to asymptomatic patients

    Medicare reimbursement for aortic stenosis patients without symptoms could accelerate procedure growth for Edwards Lifesciences, which requested the CMS review, analysts said.

    By • Dec. 16, 2025
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    Courtesy of Philips
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    Philips to acquire SpectraWAVE

    SpectraWAVE makes technologies to help diagnose and guide treatment decisions for coronary artery disease.

    By • Dec. 15, 2025
  • AtriCure’s EnCompass Clamp device is shown against a white background.
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    Retrieved from AtriCure on December 12, 2025
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    AtriCure treats first patients with dual PFA/RF system

    Combining pulsed field ablation and a radiofrequency technique in one platform is expected to reduce procedure times.

    By • Dec. 12, 2025
  • An anatomical heart is pictured in red in a transparent body.
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    Getty Images
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    Impulse Dynamics raises $158M to commercialize heart failure device

    By strengthening heart contractions, Impulse’s device could improve quality of life, restore functional capacity and enhance tolerance for exercise. 

    By • Dec. 11, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    Getty Images
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    FDA pilots allowing digital health devices access to CMS payment program

    Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.

    By • Dec. 10, 2025
  • V-Wave's implantable device for heart failure is shown next to a dime.
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    Permission granted by Johnson & Johnson
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    FDA advisory panel votes unanimously against J&J heart shunt

    Panelists focused on study data that showed the implant did not improve outcomes in heart failure patients.

    By • Dec. 5, 2025
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    Courtesy of Medline
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    PitchBook: AI tuck-in deals to drive M&A acceleration in 2026

    Buyers will focus on “tuck-ins that add AI or data-driven capabilities or can meaningfully improve scale against emerging competitors,” the analysts said.

    By • Dec. 3, 2025
  • Boston Scientific's Farawave pulsed field ablation catheter is shown against a white background.
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    Courtesy of Boston Scientific
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    CMS covers cardiac ablation in ambulatory surgery centers

    Extending Medicare reimbursement for cardiac catheter ablation to settings outside the hospital is expected to boost procedure volumes and benefit Abbott, Boston Scientific, J&J and Medtronic.

    By • Nov. 26, 2025
  • A 3D visualization of red blood cells traveling through a blood vessel.
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    Getty Images
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    Okami raises $45M to commercialize vascular embolization devices

    The company named former Inari Medical CEO Drew Hykes as its next leader in conjunction with the financing round.

    By • Nov. 24, 2025
  • Nick West, chief medical officer of J&J unit Shockwave, smiles in a headshot.
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    Permission granted by J&J MedTech
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    Q&A

    Shockwave’s Nick West on shaking up treatment for blocked arteries

    The chief medical officer for the new J&J unit discussed intravascular lithotripsy’s rapid growth and what to expect from the pipeline in a conversation with MedTech Dive.

    By • Nov. 21, 2025
  • A physician in blue scrubs and a mask looks at Philips' DeviceGuide images on a large screen.
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    Courtesy of Philips
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    Philips, Edwards team on AI-based guide for mitral valve repair

    Artificial intelligence combines ultrasound and X-ray images to give physicians a real-time 3D view of the repair device during transcatheter heart procedures.

    By • Nov. 19, 2025
  • 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 PFA business is heating up

    Pulsed field ablation sales grew by more than 300% in the second quarter for the company’s 2026 fiscal year, amid mounting competition in the space.

    By • Nov. 18, 2025
  • A rendering of a rounded device with a wire structure surrounded by mesh.
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    Courtesy of Boston Scientific
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    Boston Scientific, Siemens Healthineers partner on cardiac catheter

    Intended for use in structural heart procedures, the cardiac imaging catheter is expected to drive growth for Boston Scientific’s Watchman device.

    By • Nov. 17, 2025
  • Medtronic's Jason Fontana is wearing a blue suit and blue patterned tie in a headshot.
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    Courtesy of Medtronic
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    Q&A

    Medtronic’s Jason Fontana on ramping up renal denervation

    The general manager for the business says building a market is something the medtech giant knows how to do.

    By • Nov. 5, 2025
  • A corporate building for Edwards Lifesciences.
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    Courtesy of Edwards Lifesciences
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    Edwards CFO Scott Ullem to exit post

    Ullem, who has held the position for more than a decade, will transition to an advisory role after his replacement is named by mid-2026.

    By • Oct. 31, 2025
  • Two clinicians view data showing the condition of a patient's arteries on a large screen.
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    Courtesy of Philips
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    3 takeaways from TCT 2025

    Trials from Edwards, Philips and Penumbra were among the most-watched studies at the annual cardiovascular meeting.

    By • Oct. 31, 2025
  • Rendering of a spiral-shaped catheter with four electrodes
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    Permission granted by Medtronic
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    CMS grants NCD for renal denervation, benefiting Medtronic, Recor

    National Medicare coverage paves the way for a larger patient population to access the blood pressure treatment, which gained FDA approval in 2023.

    By • Oct. 29, 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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    Medtronic links renal denervation to 3-year blood pressure reduction

    Patients treated with Symplicity Spyral had significantly lower blood pressure than people who received a sham treatment after three years.

    By • Oct. 28, 2025
  • The robot-enhanced heart valve replacement system is depicted in an illustration that includes a patient on a table.
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    Courtesy of CardioPrecision
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    Profile

    Corcym, CardioPrecision set sights on robotic heart valve replacement

    The companies have teamed to develop an alternative to TAVR that combines the benefits of a less-invasive procedure with the longer-term advantages of open heart surgery.

    By • Oct. 27, 2025
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific continues to win in electrophysiology

    Strong sales growth in the company’s electrophysiology unit comes amid a market fight between some of the medtech industry’s largest players.

    By • Oct. 22, 2025