Policy & Regulation


  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images
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    FDA finalizes guidance on studying opioid use disorder treatments

    The Center for Devices and Radiological Health is aiming to help companies manage challenges such as inaccurate participant reports of drug use.

    By July 12, 2024
  • Loper decision ending Chevron deference doctrine
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    Anna Moneymaker / Staff via Getty Images
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    Deep Dive

    FDA’s lab developed test rule could be first check on agency’s power post-Chevron

    The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

    By , July 11, 2024
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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
  • A picture of several blood culture vials against a white background.
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    Courtesy of BD
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    FDA warns BD blood culture bottle shortage could impact diagnosis

    BD said reduced availability of blood culture media bottles due to supplier issues has prevented it from meeting global demand.

    By July 11, 2024
  • 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 recalls endotracheal tubes over blockage risk

    The Food and Drug Administration has told healthcare providers to stop using the two affected types of endotracheal tubes.

    By July 11, 2024
  • The front of the department of health and human services building with a sign in front of the exterior building
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    Mark Wilson via Getty Images
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    Federal officials step down from health AI group’s board

    HHS officials Micky Tripathi and Troy Tazbaz resigned from their roles as non-voting members of the Coalition for Health AI, an industry group working to create standards for artificial intelligence in healthcare.

    By Emily Olsen • July 10, 2024
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Roche wins CE mark for its first CGM

    The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.

    By Updated July 10, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    Pulse drops 510(k) plan for PFA device after FDA requests clinical data

    Analysts said the AFib device is now unlikely to come to market before late 2026.

    By July 9, 2024
  • Five syringes side by side with different tips.
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    Retrieved from Cardinal Health on July 02, 2024
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    FDA continues crackdown on plastic syringes made in China

    The agency has issued import bans for four manufacturers, and multiple companies have recalled affected syringes. Check out MedTech Dive’s roundup of the news.

    By July 2, 2024
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA to expand total product life cycle program

    Officials plan to start accepting radiological and ophthalmic medical devices into the program, designed to accelerate medtech innovation, in October.

    By July 2, 2024
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA shares draft guidance on clinical trial diversity action plans

    The agency said which trials need diversity action plans and presented the timeline for implementing the requirement.

    By June 28, 2024
  • Exterior of FDA headquarters
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    Courtesy of U.S. Food and Drug Administration
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    Cepheid wins FDA nod for fingerstick hepatitis C test

    Patients could be diagnosed and potentially receive treatment at the same healthcare visit.

    By June 28, 2024
  • A sign on a wall reads "Bill & Melinda Gates Foundation."
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    David Ryder via Getty Images
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    FDA partners with Gates Foundation to support breath-based diagnostic development

    Through a $1.9 million Gates Foundation grant, the collaborators will create methods to help developers make tests that can easily be deployed to rural and remote areas.

    By June 27, 2024
  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    Cardinal Health recalls procedure kits over plastic syringes made in China

    Cardinal listed more than 500 catalog numbers in its recall notice and told customers to remove and discard the syringes.

    By June 24, 2024
  • ONC head Micky Tripathi stands behind a podium.
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    Courtesy of HHS
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    Q&A

    ONC’s Micky Tripathi on laying the digital floor for healthcare AI

    The agency head discussed ONC’s accomplishments over the past two decades, artificial intelligence opportunities and improving the documentation burden among clinicians.

    By Emily Olsen • June 20, 2024
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images
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    FDA official sets out approach to AI in medical devices

    Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.

    By June 18, 2024
  • Chiquita Brooks-LaSure speaks behind a podium in front of a black background.
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    Chip Somodevilla via Getty Images
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    Senators urge CMS to create AI payment pathway

    Uniform reimbursement standards are needed to protect patient access to algorithm-based devices and ensure future innovation, the lawmakers said.

    By June 18, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    FDA creates transparency principles for AI in medical devices

    The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.

    By June 17, 2024
  • Dental tools and masks sit inside a two trays in a machine, with the door open.
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    Guillermo Spelucin Runciman via Getty Images
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    Medtech group updates EtO standard for first time in 25 years

    The Association for the Advancement of Medical Instrumentation said the changes incorporate new technologies and address industry challenges.

    By June 14, 2024
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    Sarah Silbiger via Getty Images
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    Teleflex catheter kit recall linked to 31 injuries, 3 deaths

    Teleflex reported 322 complaints about a safety problem that can prevent the balloon from fully inflating.

    By June 14, 2024
  • A picture of Philips' Duo Venous Stent System against a white background.
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    Courtesy of Philips
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    Philips launches stent system to restore blood flow in blocked veins

    Philips acquired the device as part of its 227 million euro purchase of Vesper Medical in 2022.

    By June 13, 2024
  • Two carts have mounted screens and surgical tools on them.
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    Courtesy of Johnson & Johnson
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    J&J wins expanded FDA clearance for knee surgery robot

    Johnson & Johnson has identified Velys as a product that can help it regain market share from rivals such as Stryker.

    By June 10, 2024
  • A battery that says "AAA" on the left, is compared to two small, cylindrical devices on the right.
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    Courtesy of Abbott
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    Abbott wins CE mark for dual-chamber leadless pacemaker

    Abbott sees the device as a product that can help its rhythm management business grow 6% to 7%.

    By June 7, 2024
  • Professional photo of Marcus Schabacker in an office space.
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    Permission granted by ECRI
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    Q&A

    Stronger oversight of AI needed in medical devices, ECRI CEO says

    Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.

    By June 5, 2024
  • A droplet from a pipette hangs over a series of test tubes in this stock image.
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    K-Kwanchai via Getty Images
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    Lab industry sues to stop FDA’s new LDT rule

    The American Clinical Laboratory Association argues the agency does not have the authority to enforce stricter standards on lab developed tests.

    By May 30, 2024
  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    New products take center stage in medtech’s latest earnings season

    From pulsed field ablation devices to Intuitive's latest da Vinci robot, product launches dominated recent earnings calls.

    By May 28, 2024