Cardiac

  • A robotic aortic valve replacement procedure is depicted.
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    Courtesy of CardioPrecision
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    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
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    Courtesy of HeartFlow
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    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
  • Front sign of FDA building Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • Monogram Technologies' robotic surgery system is displayed against a gray background.
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    Permission granted by Monogram Technologies
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    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.
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    hapabapa via Getty Images
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    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.
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    Courtesy of Edwards Lifesciences
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    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.
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    Alamy
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    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
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    Courtesy of HeartFlow
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    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
  • 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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    Earnings & Tariffs

    ‘We are not rolling over’: J&J electrophysiology unit rebounds amid PFA rivalry

    The division returned to growth in the second quarter after declining over the previous three months. Now, can the healthcare giant catch up with its rivals in pulsed field ablation?

    By • July 16, 2025
  • An image of Abbott's TriClip device to repair the tricuspid valve.
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    Permission granted by Abbott
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    Abbott gains national CMS coverage for tricuspid valve repair

    The agency’s decision supports broader access to a minimally invasive treatment for patients with severe tricuspid regurgitation, in which blood can leak backward into the heart.

    By • July 10, 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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    Boston Scientific gets expanded PFA label for persistent AFib

    Patients whose atrial fibrillation lasts longer than seven days and who do not respond well to drug therapy are now eligible for treatment with the Farapulse pulsed field ablation system.

    By • July 8, 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 recalls heart pump controllers after 3 patients die

    The FDA published an early alert, which the agency reserves for potentially high-risk issues.

    By • Updated July 8, 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 pulls in an additional $250M to advance PFA tech

    The funding will allow the Canadian company to pursue regulatory approvals and build up its manufacturing capabilities and commercial team ahead of a launch anticipated this year.

    By • July 7, 2025
  • Field Medical's FieldForce pulsed field ablation system for ventricular tachycardia is displayed.
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    Courtesy of Field Medical
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    Field Medical raises another $35M for PFA system

    The medtech startup founded by physician and Farapulse inventor Steven Mickelsen is preparing to begin a pivotal study of pulsed field ablation for ventricular tachycardia.

    By • July 2, 2025
  • A photo of Carmat's artificial heart device.
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    Courtesy of Carmat
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    Carmat files for insolvency amid cash crunch

    The artificial heart maker ran a crowdfunding campaign to try to raise some of the 3.5 million euros it needed to fund operations into July.

    By • July 1, 2025
  • The logo of the Food and Drug Administration is seen in a close-up view of the agency's website.
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    Mario Guti via Getty Images
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    Bivacor wins FDA breakthrough nod for titanium total artificial heart

    The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.

    By • June 2, 2025
  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Boston Scientific plans changes to expected $200M tariff hit as situation shifts

    The company also shared more details of its exit from the TAVR market and the impact of FDA layoffs on product review times.

    By • May 29, 2025
  • Boston Scientific's Acurate neo2 TAVR device is shown close up against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific ends TAVR sales; J&J shares Monarch robot data

    Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”

    By • May 28, 2025
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
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    Courtesy of Edwards Lifesciences
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    Edwards gains expanded TAVR label for asymptomatic patients

    The medical technology company expects the new indication to increase sales in its transcatheter aortic valve replacement business with more patients becoming eligible for the treatment.

    By • May 5, 2025
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic wins FDA approval for defibrillation lead

    Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, according to Medtronic.

    By • Updated May 5, 2025
  • A picture of a medical catheter against a white background.
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    Courtesy of Abbott
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    News roundup

    4 PFA studies in the spotlight at Heart Rhythm 2025

    Boston Scientific, Medtronic, Abbott and J&J unveiled new data for their PFA devices in tandem with the Heart Rhythm Society’s annual meeting.

    By • April 29, 2025
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
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    Courtesy of Edwards Lifesciences
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    Earnings & Tariffs

    Edwards shrugs off tariffs, backs 2025 profit forecast

    The heart valve specialist saw better-than-expected TAVR sales in the first quarter as hospitals addressed capacity constraints that have dogged its core business.

    By • Updated April 30, 2025
  • A headshot of Field Medical CEO Steven Mickelsen.
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    Permission granted by Field Medical
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    Field Medical raises $40M for PFA in ventricular tachycardia

    Led by Farapulse founder Steven Mickelsen, Field has developed a pulsed field ablation device to tackle the dangerous heart rhythm disorder.

    By • April 23, 2025
  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Earnings & Tariffs

    Boston Scientific is ‘very bullish’ on 2025 despite $200M tariff hit

    The company joins Johnson & Johnson and Abbott as top medtech firms that expect an impact in the hundreds of millions of dollars from President Donald Trump’s tariff policies.

    By • April 23, 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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    Intuitive, Boston Scientific and Edwards next up in medtech earnings

    Tariff talk will continue in the second week of earnings season, but the updates could also shed light on trends and competitive dynamics in key markets.

    By • April 21, 2025
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina, Tempus AI partner to drive genomic testing beyond cancer

    The partners plan to build evidence packages that standardize comprehensive genomic profiling and other molecular testing across all major diseases.

    By • April 18, 2025