FDA

  • A hand in a blue glove holds a blood sample.
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    Courtesy of Grail
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    Grail multicancer detection test wins FDA advisers’ backing

    Members of the molecular and clinical genetics panel said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings.

    By • Sept. 24, 2026
  • A MedAlliance Selution balloon stent
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    Courtesy of MedAlliance
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    Cordis wins FDA approval for sirolimus-eluting balloon

    The approval gives physicians an alternative to uncoated balloons and Boston Scientific’s paclitaxel-coated device.

    By • Sept. 22, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Getty Images
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    Cognita Imaging wins FDA contract to test LLMs in evaluating radiology AI

    Cognita’s method will test a way of evaluating AI-generated radiology reports as the FDA considers how to regulate generative AI-enabled devices.

    By • Sept. 18, 2026
  • An image of a GI robot.
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    Permission granted by Neptune Medical
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    Neptune Medical secures FDA nod for endoscopy robot

    The robot is intended to give physicians more control of the endoscope during a colonoscopy procedure, which can help with detection and removal of lesions.

    By • Sept. 18, 2026
  • A surgical instrument lies on a table covered in a blue drape.
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    Courtesy of Medtronic
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    FDA clears vessel-sealing device for Medtronic’s Hugo robot

    Widely adopted in open and laparoscopic surgeries, the LigaSure instrument is now available for use with the Hugo robotic system.

    By • Sept. 17, 2026
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    Adobe Stock

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    Sponsored by IQVIA MedTech

    Human factors isn’t a checkbox: What FDA’s eSTAR requirements mean for MedTech submissions

    FDA’s eSTAR framework raises the bar for documenting human factors and use-related risk.

    By Di Lu, Associate Director, Regulatory Affairs | Human Factors and Usability Engineering at IQVIA MedTech • Sept. 14, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    Deep Dive

    4 questions about the FDA’s approach to generative AI

    The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a discussion paper as the technology becomes more prevalent.

    By • Sept. 9, 2026
  • An image of a blue catheter.
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    Permission granted by Abbott
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    Abbott wins FDA approval for dual-energy ablation catheter

    CEO Robert Ford has said the atrial fibrillation treatment, along with the company's Volt PFA device, is expected to help Abbott regain market share in electrophysiology.

    By • Sept. 8, 2026
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    Getty Images
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    Boston Scientific recall of spinal cord stimulator leads tied to more than 1,000 injuries

    A problem with the leads could cause inadequate stimulation, Boston Scientific said. In the worst case, leads may need to be removed or replaced.

    By • Sept. 4, 2026
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    Alamy
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    Medtronic recalls pH monitoring capsule linked to 184 serious injuries

    For the second time in two years, Medtronic has pulled capsules from the market over a fault that could obstruct patients’ airways.

    By • Aug. 28, 2026
  • Surgeons perform a procedure in an operating room.
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    Courtesy of Johnson & Johnson
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    J&J’s latest Impella recall tied to 3 deaths, 37 injuries

    Hospitals can use automated controllers in inventory while waiting for service from J&J’s Abiomed business to ensure patients who need Impella heart pumps can still receive care.

    By • Aug. 27, 2026
  • An illustration of beta amyloid plaques and tau in the brain
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
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    Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test

    Labcorp and Quest Diagnostics both plan to offer the test, which secured CE mark certification earlier this year.

    By • Aug. 25, 2026
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    Sarah Silbiger via Getty Images
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    FDA adds two behavioral health firms to TEMPO pilot

    Sondermind and Limbic are evaluating digital health devices intended to help with anxiety and depression.

    By • Aug. 24, 2026
  • A nurse in green scrubs puts a smart watch on a patient in a grey, blue and orange striped shirt.
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    Getty Images
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    How can wearables be used in clinical trials? FDA outlines best practices

    Digital health technologies used in studies should be validated and measure outcomes that matter to patients, the FDA said.

    By • Aug. 21, 2026
  • A man wearing a white shirt and grey pants stands in front of a robotice blood drawing machine.
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    Courtesy of Vitestro
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    Vitestro secures FDA nod for robotic blood draw device

    The Food and Drug Administration hailed the potential of the first-of-its-kind device to counter the U.S. phlebotomist shortage. 

    By • Aug. 20, 2026
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    Sarah Silbiger via Getty Images
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    Trump nominates policy aide Overton to lead FDA

    Heidi Overton, a medical doctor and veteran of the America First think tank, currently serves as deputy director of the White House Domestic Policy Council.

    By Kristin Jensen • Aug. 19, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on generative AI regulations

    The agency published a discussion paper this week as it considers the “unique risks” and potential promise of generative AI for patient care.

    By • Aug. 19, 2026
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    Joe Raedle via Getty Images
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    FDA names second participant in TEMPO digital health pilot

    Cadence, a company that makes AI-enabled software to support hypertension management, will join the pilot, which allows companies to collect real-world data through Medicare.

    By • Aug. 17, 2026
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    Sarah Silbiger via Getty Images
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    Device firms back latest MDUFA deal, while patients want more postmarket safety

    The latest agreement includes higher fees for overseas firms, hiring transparency requirements and greater use of real-world evidence.

    By • Aug. 10, 2026
  • A Grail employee in white coat and blue gloves works with a blood sample.
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    Courtesy of Grail
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    FDA sets advisory panel for Galleri multicancer screening test

    Outside experts will convene in September to review Grail’s premarket approval application for the MCED blood test. Experts selected for the committee will be key to watch, an analyst said.

    By • Aug. 7, 2026
  • Caristo Diagnostics' CaRi-Heart technology shown on a screen.
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    Permission granted by Caristo Diagnostics
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    Caristo wins FDA authorization for cardiovascular risk predictor

    The University of Oxford spinout will soon launch the AI tool, which research suggests could help assess heart attack risk in patients who don’t have obstructive coronary artery disease.

    By • Aug. 4, 2026
  • A person in a lab coat is seen through a well-lit, organized laboratory environment featuring shelves stocked with additional lab supplies and instruments.
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    Alamy
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    The FDA was all in on AI. Will that change?

    High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

    By Kelly Bilodeau • July 29, 2026
  • A Freenome employee wearing a white coat and purple gloves is shown working in a laboratory.
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    Permission granted by Freenome
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    Freenome secures FDA nod for blood-based colorectal cancer test

    Abbott will market Freenome’s SimpleScreen CRC test in the U.S., alongside its Cologuard stool test. SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening.

    By • July 27, 2026
  • A commercial building displays a “Boston Scientific” sign on its exterior. The structure features a smooth white facade with reflective windows and minimal architectural detailing, set against a partly cloudy sky.
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    Alamy
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    Boston Scientific removes stroke prevention catheter after injury

    The device, bought during Boston Scientific’s acquisition of Silk Road Medical, has a risk of catheter tip separation during use.

    By • July 27, 2026
  • Dr. Marty Makary speaks at a press conference.
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    Andrew Harnik via Getty Images
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    Why the FDA’s top spot could sit empty for months

    Multiple factors could get in the way of confirming a new commissioner before the midterm elections, experts said, leaving the agency’s long-term initiatives in limbo.

    By Susanna Vogel • July 24, 2026