Cardiac

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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
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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
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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
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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
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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
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    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
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    Stock via Getty Images
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    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
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    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
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    Courtesy of Boston Scientific
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    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
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    Alamy
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    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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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