FDA

  • A women looks at Teal Health's at-home self-collection cervical cancer screening kit while at a counter.
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    Retrieved from Teal Health on May 13, 2025
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    Teal wins FDA approval for at-home cervical cancer screening device

    The company plans to start shipping the device in June, starting in California and then expanding nationwide.

    By • May 13, 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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    FDA, aiming to speed scientific reviews, names chief AI officer

    Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA scientists spend less time on repetitive tasks.

    By • May 9, 2025
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    Sitthiphong via Getty Images
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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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    Jack Taylor via Getty Images
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    AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK

    AdvaMed and its British counterpart called for urgent action to ensure the situation “does not devolve into a crisis.”

    By • May 7, 2025
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    Mariakray via Getty Images
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    HHS overhaul

    State attorneys general sue over ‘unconstitutional’ HHS restructuring

    The lawsuit alleges the Trump administration overstepped its authority in reshaping the federal health department and asked the court to reinstate workers laid off last month.

    By Susanna Vogel • May 7, 2025
  • Robert F. Kennedy Jr. stands in front of a podium, speaking with a hand raised.
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    Andrew Harnik via Getty Images
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    HHS overhaul

    RFK’s FDA layoffs could slow safety communications, experts warn

    The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

    By • May 6, 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
  • 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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    Andrew Harnik / Staff via Getty Images
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    Tracker

    Trump policies are upending healthcare. Track the effect on the medtech industry here.

    Robert F. Kennedy Jr. was grilled by senators on Wednesday over questions about HHS layoffs and proposed budget cuts, while AdvaMed’s CEO pleaded for tariff relief before a Senate panel.

    By MedTech Dive Staff • Updated May 15, 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
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    Sarah Silbiger via Getty Images
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    ICU Medical receives FDA warning letter over infusion pumps

    Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

    By • April 29, 2025
  • Four medtronic Hugo surgical robots
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    Courtesy of Medtronic
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    Medtronic submits Hugo soft tissue robot for FDA approval

    William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.

    By • April 28, 2025
  • A person stands outside wearing a small, square device with a cord on their belt.
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    Permission granted by Medtronic
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    Medtronic seeks FDA nod for insulin pump, furthering Abbott collab

    Receiving FDA clearance would allow Medtronic to pair its pumps with a glucose monitor being developed for the company by Abbott.

    By • April 24, 2025
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    Anna Moneymaker via Getty Images
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    Device developers advance AI plans despite Trump uncertainty

    Trump administration policies have raised questions about how the FDA will regulate AI in medical devices. AdvaMed board members think the agency should keep its leading role.

    By • April 24, 2025
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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
  • 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 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
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    Kevin Dietsch via Getty Images
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    Deep Dive // HHS overhaul

    HHS layoffs may be illegal, legal experts say

    The federal health department sidestepped normal procedures as it laid off 10,000 employees, according to sources. One union has already filed an internal complaint, while at least two law firms are exploring suits.

    By Rebecca Pifer • 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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    Kayla Bartkowski via Getty Images
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    Makary seeks to limit industry’s role in FDA advisory panels

    Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as industry representatives on advisory committees.

    By Ned Pagliarulo • Updated April 18, 2025
  • Front sign of FDA building
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    Sarah Silbiger via Getty Images
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    HHS overhaul

    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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    HHS overhaul

    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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    Win McNamee via Getty Images
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    Trump tariffs

    US launches probe that could set stage for pharma tariffs

    The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.

    By Ned Pagliarulo • Updated April 14, 2025
  • A female hematologist analyzes medical samples at a hospital laboratory.
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    andresr via Getty Images
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    Deep Dive

    A judge blocked the FDA’s plan to regulate LDTs. What now?

    One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but Congress could still take on the issue.

    By • April 16, 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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    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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    Kevin Dietsch via Getty Images
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    RFK Jr. won’t appear before Senate panel this week

    HELP committee chair Bill Cassidy, R-La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A hearing could still take place later. 

    By Ned Pagliarulo • April 8, 2025