Clinical Trials: Page 3

  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
    Image attribution tooltip
    Courtesy of Exact Sciences
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Business Wire
    Image attribution tooltip

    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
  • the FDA Headquarters Explore the Trendline➔
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip
    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
  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip

    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.
    Image attribution tooltip
    Mario Tama via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    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
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Mohammed Haneefa Nizamudeen via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip

    Photo illustration: Shaun Lucas/Industry Dive; CRISPR Therapeutics; Gregor Fischer/DPA/Newscom

    Image attribution tooltip
    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.
    Image attribution tooltip
    Permission granted by Empatica
    Image attribution tooltip

    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
  • Image attribution tooltip
    Christopher Furlong via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    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
  • Boston Scientific's Farapulse pulsed field ablation PFA generator and catheter
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip

    Large registry study upholds safety findings for Boston Scientific’s Farapulse device

    The results, presented at the American Heart Association Scientific Sessions, showed a low rate of adverse events for the pulsed-field ablation treatment.

    By • Nov. 14, 2023
  • President Joe Biden signs a presidential memorandum that will establish the first-ever White House Initiative on Women’s Health Research.
    Image attribution tooltip
    Win McNamee/Getty Images via Getty Images
    Image attribution tooltip

    Biden initiative aims to accelerate women’s health research

    AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.

    By • Nov. 14, 2023
  • An injection pen containing the drug semaglutide lies on a white plate.
    Image attribution tooltip
    Douglas Cliff via Getty Images
    Image attribution tooltip

    Wegovy study details revive debate over GLP-1 impact on devices

    The data confirmed a cardiovascular benefit for heart patients and showed the drug could help pre-diabetic patients control their blood sugar.

    By • Nov. 13, 2023
  • A blue catheter with a metal tip
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study

    Scores on a quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device.

    By • Nov. 6, 2023
  • A device with a clear cylinder in the middle and tubing coming out of the top.
    Image attribution tooltip
    Permission granted by Penumbra
    Image attribution tooltip

    Penumbra touts benefits of vacuum thrombectomy for PE in late-breaking data

    An interim analysis of Penumbra’s Indigo aspiration system met its primary safety and efficacy criteria, according to data shared at the Vascular Interventional Advances Conference.

    By • Nov. 3, 2023
  • A circular device with a metal mesh around it.
    Image attribution tooltip
    Courtesy of Edwards Lifesciences
    Image attribution tooltip

    Edwards posts early look at tricuspid device, stoking Abbott rivalry ahead of FDA panel

    Nearly 94% of patients had their condition improve to mild or no tricuspid regurgitation six months after treatment, according to the study.

    By • Oct. 27, 2023
  • Abbott Laboratories
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    Abbott’s resorbable scaffold improves outcomes in below-the-knee artery disease, study finds

    The device maker plans to submit the Esprit BTK data to the Food and Drug Administration for review.

    By • Oct. 26, 2023
  • Illustration of a catheter with a cylindrical sheath
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip

    Boston Scientific study results support coronary drug-coated balloon in US

    The results, shared at TCT 2023, found the company’s drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries.

    By • Oct. 25, 2023
  • An anatomical heart is pictured in red in a transparent body.
    Image attribution tooltip
    magicmine via Getty Images
    Image attribution tooltip

    Edwards, Medtronic post low-risk TAVR data, allaying fears of market disruption

    The late-breaking results, shared at TCT 2023, will have little impact on clinical practice or market share, J.P. Morgan and Stifel analysts predicted.

    By • Oct. 25, 2023
  • An image of the Edwards Sapien 3 Ultra Resilia transcatheter aortic heart valve
    Image attribution tooltip
    Courtesy of https://www.edwards.com/devices/heart-valves/transcatheter-SAPIEN-3-Ultra
    Image attribution tooltip

    Physicians forecast Edwards’ 5-year data will have limited impact on low-risk TAVR market

    Some doctors think TAVR may perform numerically worse but see little impact on the market unless there is a statistically significant result.

    By • Oct. 20, 2023
  • doctor on telehealth, telemedicine service analyzing online on EHR, EMR patient digita data on tablet in lab
    Image attribution tooltip
    Retrieved from Adobe Stock.
    Image attribution tooltip

    Duke researchers find app improves autism screening in NIH-funded study

    Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.

    By • Oct. 4, 2023
  • A person wearing a blue glove holds a test tube with red liquid
    Image attribution tooltip
    Dmitry Belyaev via Getty Images
    Image attribution tooltip

    Harbinger Health raises $140M to study blood-based cancer screening test

    The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.

    By • Sept. 28, 2023
  • An illustration of two lungs on a scientific background colored orange.
    Image attribution tooltip
    Mohammed Haneefa Nizamudeen via Getty Images
    Image attribution tooltip

    Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts

    It is not yet clear how different approaches would benefit specific patients, creating uncertainty about which businesses will profit from the shift.

    By • Sept. 26, 2023