Clinical Trials: Page 2


  • An exterior of a building with a sign that says "Welcome to #MTC24" in front of a downtown skyline.
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    Elise Reuter/MedTech Dive
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    The Medtech Conference

    That’s a wrap: 5 takeaways from The Medtech Conference

    The conference — Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.

    By Oct. 22, 2024
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    Courtesy of Abbott
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    Abbott enrolls pivotal PFA study 4 months ahead of schedule

    The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.

    By Oct. 11, 2024
  • An image of the Procept Biorobotics system against a white background.
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    Courtesy of Procept Biorobotics
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    Procept secures FDA approval to study surgical robot in prostate cancer

    The trial will compare the therapy to radical prostatectomy and could unlock a market that analysts value at $500 million.

    By Oct. 9, 2024
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    halbergman via Getty Images
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    Top medtech conferences in 2025

    The lineup includes industrywide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.

    By Updated Jan. 23, 2025
  • A picture of Synchron's brain-computer interface device against a white background.
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    Courtesy of Synchron
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    Synchron’s brain-computer interface tech meets safety goal

    The six-patient trial also indicated the device worked, according to Synchron, with the conversion of brain signals to motor outputs allowing people to perform digital tasks.

    By Oct. 1, 2024
  • Senior Research Associate Tanya Quint loads one of the instruments used to run Exact Sciences' Cologuard test at the company's headquarters in Madison, Wis. (Photo: Business Wire)
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    Courtesy of Business Wire/Exact Sciences
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    Exact Sciences says data support its colon cancer blood test

    Exact’s test could compete with Guardant Health’s Shield blood test, which received approval from the Food and Drug Administration in July.

    By Sept. 16, 2024
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on health equity for medical devices

    The agency plans to develop a framework for when devices should be evaluated in diverse populations to support marketing authorization.

    By Aug. 6, 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 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
  • 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
  • A person sits in front of a plate of food, holding a smartphone. They're wearing a patch on their left arm.
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    Courtesy of Insulet Corp.
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    Insulet seeks label expansion of Omnipod 5 for Type 2 diabetes

    At the American Diabetes Association meeting, Insulet shared study results showing improvements in blood glucose and quality of life.

    By June 24, 2024
  • A female doctor and senior patient discuss medical records.
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    SDI Productions via Getty Images
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    Women underrepresented in trials of high-risk medical implants: study

    A median of 33% of study subjects were women, and the figure was significantly lower in cardiovascular trials.

    By June 12, 2024
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
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    Courtesy of Edwards Lifesciences
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    Sapien valve performs equally well for small and large aortic annuli, Edwards finds

    The analysis adds to a debate about the effectiveness of Edwards versus Medtronic TAVR devices in patients with small aortic annuli, a fibrous ring around the heart’s valve.

    By June 6, 2024
  • Prostate cancer cells, 3D illustration. Prostate cancer awareness image
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    Dr_Microbe via Getty Images
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    Saliva test identifies men at high risk of prostate cancer

    Data presented at the American Society of Clinical Oncology meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.

    By June 5, 2024
  • Photo of Michael F. Mahoney, CEO of Boston Scientific.
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    Courtesy of Boston Scientific
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    Boston Scientific’s cardiac rhythm system hits pivotal trial goals

    Boston Scientific, which presented the results at the Heart Rhythm Society meeting, expects to receive FDA approval for the system in 2025.

    By May 21, 2024
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    J&J posts latest Varipulse data while awaiting FDA review

    Johnson & Johnson is chasing Medtronic and Boston Scientific in the U.S. for a share of the rapidly growing pulsed field ablation market.

    By May 20, 2024
  • The latest Apple Watch will include entirely fiber-based packaging for the first time
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    Justin Sullivan via Getty Images
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    FDA qualifies Apple Watch AFib feature for use in clinical trials

    Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices. 

    By May 6, 2024
  • A white sign with the word Lilly written in red stands outside of an office.
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    Scott Olson via Getty Images
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    Lilly obesity drug shows benefit in sleep disorder study, pointing to new use

    Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.

    By Jonathan Gardner • April 17, 2024
  • A corporate building for Edwards Lifesciences.
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    Courtesy of Edwards Lifesciences
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    Edwards pushes back on Medtronic’s head-to-head TAVR trial

    Edwards Lifesciences and Wall Street analysts questioned the results of Medtronic’s women-focused study, claiming the data are inconsistent with real-world evidence.

    By April 15, 2024
  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
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    Courtesy of Exact Sciences
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    Exact Sciences’ cancer blood test achieves 51% sensitivity in prospective trial

    Sensitivity for the multi-cancer early detection test rose to almost 64% in the six cancers with the shortest five-year survival rate.

    By April 9, 2024
  • Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients
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    Permission granted by Medtronic
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    Medtronic beats Edwards on valve dysfunction in TAVR study

    In a head-to-head clinical trial, Medtronic linked its device to a lower rate of valve dysfunction than Edwards’ rival product in a subpopulation of patients.

    By April 8, 2024
  • A person wearing a blue glove holds a test tube with red liquid
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    Dmitry Belyaev via Getty Images
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    Freenome’s colorectal cancer blood test data underwhelm analysts

    Cowen analysts said Freenome’s results are good news for competitors Exact Sciences and Guardant Health.

    By April 5, 2024
  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
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    Courtesy of Exact Sciences
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    Exact Sciences, Mayo Clinic share early data on esophageal cancer test

    Designed as an alternative to endoscopy, the cancer screening test uses a sponge collection device that's paired with an algorithm.

    By March 29, 2024
  • A lab technician runs Guardant Health's Shield blood test for colorectal cancer screening in a lab.
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    Courtesy of Business Wire
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    Guardant posts data for colon cancer blood test amid push from rivals

    The NEJM paper presents data from a study of more than 10,000 people Guardant ran to support authorization of its Shield DNA test.

    By March 18, 2024
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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    BD starts trial of vascular covered stent in peripheral arterial disease

    Peripheral vascular disease is one of six key platforms BD is targeting for growth.

    By March 5, 2024
  • Signs for Johnson & Johnson are seen on company offices in California.
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    Mario Tama via Getty Images
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    J&J unveils Varipulse data at AF Symposium

    The results compare favorably to data from Boston Scientific and Medtronic, although analysts noted that J&J enrolled younger patients.

    By Feb. 6, 2024