Medical Devices

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    Sarah Silbiger via Getty Images
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    FDA issues early alert for BD catheters due to leaks

    BD recalled certain intravascular catheters tied to reports of 10 serious injuries after finding an increase in cracks from “material fatigue.”

    By • April 21, 2025
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    Courtesy of Precision Neuroscience
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    Precision Neuroscience receives FDA clearance for brain implant

    The electrode array, which can be implanted for 30 days to map brain activity, is a component of Precision Neuroscience’s planned brain-computer interface system.

    By • April 21, 2025
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Courtesy of Medtronic
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    Medtronic gets FDA approval to use Simplera Sync glucose sensor with insulin pumps

    The updated device allows users to pair the sensor with Medtronic’s insulin pumps, and is expected to grow the company’s diabetes business.

    By • April 21, 2025
  • U.S. President Donald Trump watches as Health and Human Services Secretary Robert F. Kennedy Jr. (C) swears in Dr. Mehmet Oz (R) as the Medicare and Medicaid Services Administrator during a ceremony in the Oval Office at the White House on April 18, 2025 in Washington, DC.
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    Dr. Oz sworn in as CMS administrator

    During a ceremony at the Oval Office, Mehmet Oz said he would focus on reducing chronic disease, “modernizing” Medicare and Medicaid, and targeting fraud, waste and abuse in government insurance offerings.

    By Emily Olsen • April 21, 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
  • An older patient in a hospital bed wearing a seizure-detecting headset with doctors around him.
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    Retrieved from Ceribell on April 17, 2025
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    Ceribell wins FDA nod for algorithm to detect pediatric seizures

    The clearance adds another feature for Ceribell to leverage as it tries to persuade hospitals to switch from conventional EEG systems.

    By • April 21, 2025
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    Laurel Deppen/MedTech Dive
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    Illinois, Minnesota join FTC challenge against $627M Surmodics buyout

    The Illinois attorney general said the deal represents a “troubling trend of wealthy investors attempting to limit competition and innovation.”

    By • April 18, 2025
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    Sarah Silbiger via Getty Images
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    FDA cuts outlined in draft HHS budget

    The draft budget would slash FDA’s budget authority, if approved by Congress.

    By • April 18, 2025
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    Andrew Harnik via Getty Images
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    Budget draft outlines Trump’s plan to slash federal health programs

    An OMB document proposes to cut the HHS budget by roughly one-third as well as eliminate several divisions and programs.

    By Sydney Halleman • April 17, 2025
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    saengsuriya13 via Getty Images
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    DaVita hit by ransomware attack

    The kidney dialysis firm doesn’t have an estimate for how long disruption from the attack will last, though DaVita stressed it’s continuing to provide patient care.

    By Emily Olsen • April 17, 2025
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott expects a ‘few hundred million’ in tariff costs in 2025

    CEO Robert Ford told investors the company had considered raising its earnings forecast for 2025, but decided to maintain it in light of the new tariffs.

    By • April 16, 2025
  • Commerce Secretary Howard Lutnick speaks during a cabinet meeting at the White House on March 24, 2025.
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    Win McNamee via Getty Images
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    Trump tariffs

    US launches probe into semiconductor imports

    The Section 232 investigation comes ahead of anticipated tariffs on the industry.

    By Philip Neuffer • April 15, 2025
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    Permission granted by Johnson & Johnson
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    Trump tariffs

    J&J expects tariff charge of $400M this year

    CFO Joe Wolk, who revealed the figure Tuesday morning on CNBC, told investors the charge was primarily in the healthcare giant’s medtech business.

    By • April 15, 2025
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    J&J completes first surgeries with Ottava robot

    Johnson & Johnson plans to seek a U.S. indication for multiple general surgery procedures, including gastric bypass, which was performed in the clinical trial.

    By • April 15, 2025
  • An image of Edwards Lifesciences' Irvine, California, campus at dusk.
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    Courtesy of Edwards Lifesciences
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    Edwards receives CE mark for Sapien M3 mitral valve replacement device

    The replacement system is launching into markets already served by repair devices, namely Edwards’ Pascal and Abbott’s Mitraclip.

    By • April 15, 2025
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    Apu Gomes via Getty Images
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    Trump tariffs

    Tariffs top of mind for medtech firms this earnings season

    GE Healthcare and Medtronic said they are preparing mitigation plans as they assess the potential ramifications of Trump’s tariff policies.

    By • April 14, 2025
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    Foremniakowski via Getty Images
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    Late-stage digital health funding rebounds in Q1: Rock Health

    The median deal size for late-stage funding rounds was $105 million, nearly double the $55 million check size across 2024.

    By Emily Olsen • April 14, 2025
  • A surgeon in blue scrubs and a facemask examines a da Vinic robotic surgery system in an operating room.
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    Retrieved from Intuitive Surgical on April 11, 2025
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    Intuitive wins FDA clearance for single-port robotic surgery stapler

    CFO Jamie Samath said in January that the stapler clearance would trigger the start of “broad commercial efforts” for the single-port system.

    By • April 11, 2025
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    Spencer Platt / Staff via Getty Images
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    Trump tariffs

    Tariff turmoil: Hospitals, device makers welcome pause, but fear long-term pain

    Healthcare providers and medtech companies still face pressure to find ways to offset potential supply chain shocks despite the latest about-face in President Donald Trump’s tariff wars.

    By Susanna Vogel , • April 10, 2025
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    Courtesy of Dexcom
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    Dexcom nets FDA clearance for 15-day CGM

    The longer wear time should improve Dexcom’s margins and help it compete with Abbott, RBC Capital Markets analyst Shagun Singh said.

    By • April 10, 2025
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    Stringer via Getty Images
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    News roundup

    Microbot posts pivotal surgical robot data; GE Healthcare hires Patient Care Solutions leader

    Microbot reported positive data on its single-use endovascular robot. Elsewhere, GE Healthcare named a new business leader, and Puzzle Medical Devices raised $31 million.

    By • April 10, 2025
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    Photo illustration: Shaun Lucas/Industry Dive; Getty Images

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    Teleflex to close Minnesota facility, cut 101 employees

    The restructuring plan comes about six weeks after Teleflex announced it would split into two separate, public entities.

    By • April 10, 2025
  • President Donald Trump speaks in the Oval Office of the White House on April 7, 2025.
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    Kevin Dietsch via Getty Images
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    Trump pauses most reciprocal tariffs, hikes China’s further

    The U.S. will now charge a 125% duty on imports from China, while most other countries will be subject to a 10% rate for 90 days.

    By Philip Neuffer • April 10, 2025
  • President Donald Trump attends a cabinet meeting at the White House on Feb. 26, 2025.
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    Andrew Harnik via Getty Images
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    Trump tariffs

    Trump’s tariffs: Tracking the status of international trade actions

    The U.S. has rolled out a deluge of tariffs, sparking responses from trading partners. Here's where each tariff — threatened or realized — currently stands.

    By Philip Neuffer , Edwin Lopez • April 9, 2025
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    Naeblys via Getty Images
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    Kandu Health merges with BCI company Neurolutions

    The merger brings together Neurolutions’ brain computer interface technology and Kandu Health’s telehealth services to try to improve stroke care.

    By • April 9, 2025