The Latest

  • The facade of the U.S. Capitol building is seen along with trees and a reflection pond
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    Kara Arundel/MedTech Dive
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    Time’s up: Enhanced ACA subsidies expire

    The expanded tax credits are officially dead after lawmakers failed to secure an extension before the end-of-year deadline. There’s still a chance, though a small one, that they could come back in 2026.

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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.

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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.

  • 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.

  • 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.

  • A person holds a phone, wearing a white patch on their forearm and an insulin pump on their hip.
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    Courtesy of Medtronic
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    Medtronic’s diabetes spinoff MiniMed files for IPO

    MiniMed is pitching the breadth of its portfolio as an advantage over more focused rivals such as Dexcom and Insulet.

  • Doctor, team and tablet in discussion with senior for healthcare training, advise or support at hospital.
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    stock.adobe.com/Kay A/peopleimages.com

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    HHS seeks input on speeding AI adoption in clinical care

    The request for information comes as the Trump administration has largely taken a deregulatory stance on AI, in a bid to avoid hampering the technology’s rollout.

    AI
  • Blue and yellow flags bearing the European Commission logo fly in front of a building.
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    Carl Court via Getty Images
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    EU proposal would simplify Medical Device Regulation

    If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare disease treatments.

  • Neurosurgeon Vitor Mendes Pereira performs a robotic aneurysm procedure while seated at a console in Panama as other clinicians observe.
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    Permission granted by XCath
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    Profile

    XCath targets better brain aneurysm outcomes with robotic approach

    The Houston-based startup is developing capabilities for endovascular aneurysm repair and stroke treatment that it hopes can bridge a skills gap and get patients treated faster.

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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.

  • A picture of Moon Surgical's Maestro robotic surgery system.
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    Permission granted by Moon Surgical
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    Moon Surgical adds 5G and Wi-Fi to Maestro robots for cloud-based AI

    The company provided an update on its efforts to win market share, revealing that Maestro has been used to treat over 2,300 patients across all sites of care.

  • CMR Surgical's Versius Plus robotic system is shown in blue lighting.
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    Permission granted by CMR Surgical
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    Robot developers make strides in 2025

    Medtronic and CMR Surgical got the FDA’s green light this month, while SS Innovations applied for clearance. Catch up on the latest in surgical robotics in this coverage roundup.

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    Kayla Bartkowski via Getty Images
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    House passes Republican health bill without ACA subsidy extension

    The legislation makes no mention of the financial assistance, setting the subsidies up to lapse in just a few weeks.

  • Professional photo of Josh Makower
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    Permission granted by DaVita
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    Dialysis cannulation can be difficult. A startup is working to improve it.

    X9 is building an ultrasound-guided device used to simplify the process of inserting a needle for cannulation.

  • CMR Surgical's Versius Plus robotic system is shown against a white background.
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    Permission granted by CMR Surgical
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    CMR Surgical gains FDA clearance for new robot

    As competition intensifies among surgical robot makers, CMR said its soft tissue platforms are the second most used systems in the world.

  • Sen. Ron Wyden speaks to reporters following a regular Democratic policy luncheon on April 8, 2025. Wyden is holding up the nomination of Sean Plankey to become director of CISA.
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    Andrew Harnik via Getty Images
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    Wyden pushes EHR vendors to adopt data privacy features

    The influential senator pressed 10 health IT and EHR firms to implement features that give patients more control over the flow of their health data.

  • 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.

  • FDA headquarters sign
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    Getty Images
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    FDA gets mixed feedback on performance monitoring for AI

    Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.

  • 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 needs more staff, authority to oversee device recalls, watchdog finds

    “FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.

  • A person wearing scrubs, a mask and a cap looks at a screen with images.
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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.

  • 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.

  • U.S. President Donald Trump in the Oval Office at the White House.
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    Andrew Harnik via Getty Images
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    Trump calls for federal policy framework preempting state AI laws

    The executive order comes as Big Tech pushes back on local AI regulation while pouring billions into building out AI infrastructure and deploying new products.

    AI
  • The top of the U.S. Capitol Building's dome is pictured on a cloudy day.
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    Win McNamee via Getty Images
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    Senate rejects competing health bills, setting up ACA subsidy lapse

    The failure of bills from both sides of the aisle means enhanced subsidies for Affordable Care Act plans will likely expire at the end of the year. Healthcare groups urged lawmakers to extend the subsidies, noting premiums could skyrocket.

  • A person sits in a white chair and looks to the side.
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    Mick Farrell named chair of AdvaMed board

    The Resmed CEO will serve a two-year term on the medtech lobbying group’s board.

  • A modern office building with large reflective glass windows is shown behind a wide driveway and landscaped entrance. In the foreground, a white and orange monument sign reads "Intuitive Surgical" with the number "1020" vertically on the side.
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    Alamy
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    Intuitive wins 3 new indications for da Vinci SP system

    The robotic surgery market leader’s single port system can now be used in inguinal hernia repair, gallbladder removal and appendectomy procedures.