Cardiac

  • 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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by Pulse Biosciences
    Image attribution tooltip

    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
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip
    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
  • FDA
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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
  • A coil-shaped device is shown moving through a tube with branching structures around it.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Kardium
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    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
  • illustration of a heart showing a tube-shaped device going into the left ventricle
    Image attribution tooltip
    Courtesy of Abiomed
    Image attribution tooltip

    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
  • Front sign of FDA building
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Deep Dive

    4 medtech topics to watch for the rest of 2025

    From M&A to MDUFA and the developing market in renal denervation, MedTech Dive covers the key issues to watch in the final months of the year.

    By , , • Aug. 25, 2025
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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 person wearing a black wristband holds a phone that says "103/65"
    Image attribution tooltip
    Permission granted by Aktiia
    Image attribution tooltip
    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
  • 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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Kardium
    Image attribution tooltip

    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
  • Reprieve Cardiovascular CEO Mark Pacyna smiles in a headshot.
    Image attribution tooltip
    Permission granted by Reprieve Cardiovascular
    Image attribution tooltip

    Reprieve Cardiovascular raises $61M; Conformal Medical nets $32M for LAAO

    The fresh funding will support pivotal trials in progress and commercialization preparations at the two heart-focused companies.

    By • Aug. 14, 2025
  • human heart
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    Cardiosense appoints John Martin as chief medical officer

    The appointment comes weeks after the company received 510(k) clearance for its wearable heart monitor.

    By • Aug. 13, 2025
  • Heartflow
    Image attribution tooltip
    Courtesy of HeartFlow
    Image attribution tooltip

    Heartflow’s IPO raises $364M

    The company’s stock rose in its first two days on public markets, closing on Monday up almost 58% over the IPO price amid investor enthusiasm.

    By • Aug. 12, 2025
  • A closeup of Boston Scientific's Watchman FLX device is shown against a white background.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    Boston Scientific updates instructions of devices linked to 17 deaths

    The update covers devices used in procedures to implant the company’s Watchman heart device.

    By • Aug. 8, 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.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Boston Scientific tells users about defibrillator problem linked to deaths, injuries

    A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.

    By • Aug. 7, 2025
  • A robotic aortic valve replacement procedure is depicted.
    Image attribution tooltip
    Courtesy of CardioPrecision
    Image attribution tooltip

    First Corcym aortic valve implanted via new robotic procedure

    CEO Christian Mazzi said the minimally invasive surgical technique could provide better outcomes for patients than transcatheter aortic valve replacement.

    By • Aug. 5, 2025
  • Heartflow
    Image attribution tooltip
    Courtesy of HeartFlow
    Image attribution tooltip

    Heartflow prices IPO, aiming to net about $180M

    The company, which sells software for creating 3D heart models, plans to offer 12.5 million shares at a range of $15 to $17 per share.

    By • Aug. 4, 2025
  • Monogram Technologies' robotic surgery system is displayed against a gray background.
    Image attribution tooltip
    Permission granted by Monogram Technologies
    Image attribution tooltip
    News roundup

    Monogram robot marks autonomy milestone; Stereotaxis catheter cleared

    Monogram Technologies conducted its first fully autonomous robotic knee replacement surgery, while Stereotaxis won FDA clearance for a robotically navigated electrophysiology mapping catheter.

    By • July 31, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
    Image attribution tooltip
    hapabapa via Getty Images
    Image attribution tooltip

    Cardiosense wins FDA clearance for wearable heart monitor

    The device captures various types of heart data that could be used in AI models for cardiovascular parameters with the aim of lowering barriers to monitoring.

    By • July 31, 2025
  • Edwards Lifesciences' Sapien 3 Ultra heart valve replacement system is shown with the valve expanded by a balloon.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    Edwards loses longtime TAVR leader Larry Wood

    Wood, who helped build Edwards’ TAVR business, will become CEO of Procept BioRobotics. Edwards also raised its sales and earnings outlook for the full year.

    By • July 25, 2025
  • A modern architectural design building featuring a red-brick façade with large glass windows displays a prominent sign of the Food and Drug Administration.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Edwards recalls arterial cannulas over exposed wires

    Exposed wires could puncture the artery and cause bleeding, inadequate perfusion and hemolysis, the FDA said in its Class I recall notice.

    By • July 25, 2025
  • Heartflow
    Image attribution tooltip
    Courtesy of HeartFlow
    Image attribution tooltip

    Heartflow files for IPO

    The company reported revenue of $37.2 million in the first quarter, up 39% year over year, but said it has faced challenges in achieving higher rates of adoption in the past.

    By • July 21, 2025