Clinical Trials: Page 3

  • 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    FDA shares draft guidance on clinical trial diversity action plans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
  • the FDA Headquarters Explore the Trendline➔
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • A female doctor and senior patient discuss medical records.
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    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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    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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    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
  • 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’s closed-loop neuromodulation device cuts overstimulation in trial

    Most participants reported a significant reduction in overstimulation compared to open-loop spinal cord stimulation.

    By • Jan. 22, 2024
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott starts study of PFA device in humans, targets 2024 US trial

    RBC analysts predict Volt could launch in the U.S. as early as 2026.

    By • Jan. 19, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    FDA drafts guidance outlining real-world evidence for medical device submissions

    By issuing the new guidance, the agency is meeting the requirements of a year-end spending bill.

    By • Dec. 19, 2023
  • An illustration of two lungs on a scientific background colored orange.
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    Getty Images
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    Freenome starts 20,000-subject study of lung cancer blood test

    The privately held company claims its test could offer an alternative to CT imaging, which exposes people to radiation.

    By • Dec. 14, 2023
  • A needle is seen piercing a cell membrane in a composite image behind an office building.
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    Photo illustration: Shaun Lucas/Industry Dive; CRISPR Therapeutics; Gregor Fischer/DPA/Newscom

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    Deep Dive

    ‘No tolerance for failure’: An oral history of the first CRISPR medicine

    A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.

    By Ned Pagliarulo , • Dec. 13, 2023
  • Empatica's Embrace smartwatches.
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    Permission granted by Empatica
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    Empatica aims to develop seizure-forecasting algorithm based on wearable data

    The company plans a study using its wrist-worn device to capture real-world data that could help understand and predict seizures for people with epilepsy.

    By • Dec. 1, 2023
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    Christopher Furlong via Getty Images
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    AstraZeneca creates digital health unit, with big-name partnerships already in place

    Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.

    By Jacob Bell • Nov. 20, 2023
  • Abbott HeartMate 3 left ventricular assist device
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    Courtesy of Abbott
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    Abbott study links aspirin-free regimen to better outcomes in heart pump patients

    An accompanying editorial said the “data provide an opportunity to immediately improve the outcomes of patients implanted with contemporary LVADs.”

    By • Nov. 15, 2023