Cardiac: Page 2

  • Person wears Oura ring in a car
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    Courtesy of Oura
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    Ōura to pursue FDA clearance of blood pressure feature for smart ring

    The company has received approval to validate and define the feature in a study that is scheduled to start this year.

    By • Oct. 20, 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 CEO: ‘We’re right on time’ to the PFA party

    As competitors have launched their first pulsed field ablation devices in the U.S., Abbott CEO Robert Ford told investors that the company is not just playing defense.

    By • Oct. 15, 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
  • An anatomical heart is pictured in red in a transparent body.
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    Getty Images
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    Stereotaxis teams with CardioFocus to develop robotic PFA system

    Stereotaxis CEO David Fischel said the precision, stability and safety profile of robotics are a good fit for pulsed field ablation.

    By • Oct. 15, 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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    Cybersecurity triggers another recall of J&J’s Impella heart pump controller

    While no patients have been harmed, the FDA categorized the action as a Class I recall because of the potential for serious injury or death.

    By • Oct. 14, 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 wins CE mark for Penditure LAA exclusion device

    The company plans to launch the device in Europe late next week, providing competition for AtriCure’s AtriClip product.

    By • Oct. 3, 2025
  • Boston Scientific's Farapulse pulsed field ablation device.
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    Permission granted by Boston Scientific
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    Boston Scientific aims for market leadership in electrophysiology

    The company has now treated 500,000 patients with its pulsed field ablation system, in a competitive category poised for growth.

    By • Oct. 2, 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 unveils plans for new Watchman device

    The company hopes to launch its next-generation Watchman system in the second half of 2027 or early 2028.

    By • Updated Oct. 14, 2025
  • Heartflow
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    Courtesy of HeartFlow
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    Heartflow receives FDA clearance for updated plaque analysis platform

    The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.

    By • Sept. 25, 2025
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    Getty Images
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    Cardiosense names Eric Meizlish as CEO

    Cardiosense’s switch to a leader with experience scaling healthtech companies comes as it works to build on the recent 510(k) clearance of CardioTag.

    By • Updated Sept. 25, 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’s Abiomed starts third heart pump controller recall since June

    As of Aug. 27, the company had reported five serious injuries and no deaths associated with the issue.

    By • Sept. 24, 2025
  • SS Innovations CEO Sudhir Srivastava is seated at the surgeon's console of the company's SSi Mantra robotic surgery system.
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    Permission granted by SS Innovations
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    Profile

    How SS Innovations is expanding robotic surgery’s reach

    Heart surgeon Sudhir Srivastava saw a global need for less-invasive surgical care at an affordable price. His company, SS Innovations, built a robot that has now been used in more than 5,000 surgeries.

    By • Sept. 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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    FDA posts early alert about Abbott’s Tactiflex Ablation Catheter

    Catheter tips came off three damaged devices during surgery but none of the patients suffered serious injuries or died.

    By • Updated Sept. 22, 2025
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    J&J launches IVL device in Europe; Medtronic looks at pacing for more patients

    J&J’s Shockwave Javelin intravascular lithotripsy catheter treats people with peripheral artery disease. Elsewhere, Medtronic began a pivotal trial to evaluate its pacemakers in a new patient group.

    By • Sept. 18, 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
  • FDA
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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
  • 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
  • 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
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    Sarah Silbiger via Getty Images
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    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.
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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 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
  • 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