Clinical Trials: Page 2


  • iRhythm Zio XT
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    Permission granted by iRhythm

    iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients

    Data presented at ACC's Scientific Sessions show that by using iRhythm's Zio to monitor patients after discharge, physicians reduced hospital stays and potentially improved identification of arrhythmia.

    By April 4, 2022
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    Carl Court via Getty Images

    US replaces EU as priority market for medtech industry: survey

    A survey of more than 100 executives at medical device companies found 89% of medtechs plan to prioritize U.S. regulatory approval going forward. One CEO said the EU's Medical Device Regulation "is killing innovation."

    By March 16, 2022
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    Courtesy of Guardant Health

    Q&A

    Guardant Health targets colorectal cancer screening in 2022

    CEO Helmy Eltoukhy tells MedTech Dive the precision oncology company plans to launch a liquid biopsy in the first half of the year, rivaling Exact Sciences' Cologuard stool test.

    By Feb. 8, 2022
  • Red human heart drawing on blue background
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    Jolygon via Getty Images

    Edwards-backed Corvia fails pivotal heart failure trial but clings to subgroup efficacy signal

    Corvia Medical's atrial shunt therapy has failed to improve cardiovascular disease outcomes in heart failure patients, according to clinical trial results. 

    By Feb. 2, 2022
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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    Sarah Silbiger via Getty Images

    FDA finalizes two guidances on including patient perspectives in medtech clinical trials

    The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

    By Jan. 26, 2022
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    Dollar Photo Club

    Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests

    A study found Exact's second-generation stool test has a lower false positive rate than the current product and is better at detecting precancerous lesions. But it is facing competing blood tests from Freenome and Guardant Health.

    By Jan. 20, 2022
  • User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

    Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

    Dec. 28, 2021
  • Neurostimulator to treat stroke fails to gain FDA advisory panel support

    The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.

    By Dec. 13, 2021
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient.
    Image attribution tooltip
    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    Vaccine makers move quickly to confront omicron threat

    Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.

    By Ned Pagliarulo • Nov. 29, 2021
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images

    FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

    The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country. 

    By Ben Fidler • Nov. 19, 2021
  • Boston Scientific Watchman FLX left atrial appendage closure device
    Image attribution tooltip
    Courtesy of Boston Scientific

    Latest Abbott, Boston Scientific LAAC devices yield mixed results in first clinical comparison

    No clear difference was evident in clinical outcomes at 45 days, but other endpoints did point toward potential pros and cons of the two left atrial appendage closure devices.

    By Nov. 8, 2021
  • Edwards, Medtronic bolster economic, clinical case for using TAVR over surgery

    Medtronic released five-year data from the SURTAVI trial while Edwards presented a two-year study of the costs of TAVR and surgery, both of which were late-breaking clinical trials at the TCT annual scientific symposium.

    By Nov. 8, 2021
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images

    Siemens' Varian leads latest FDA breakthrough device designations

    Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

    By Nov. 1, 2021
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    Permission granted by Medtronic, Megan Rosengarten
    Q&A

    Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges

    Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.

    By Oct. 20, 2021
  • Medtronic misses bid for early FDA OK in renal denervation, stock slides

    The independent data safety monitoring board found the clinical trial needs to keep enrolling patients and gather results to show if the treatment works.

    By Oct. 18, 2021
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images

    Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

    Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

    By Sept. 8, 2021
  • Abbott Laboratories
    Image attribution tooltip
    Courtesy of Abbott

    COVID-19 seems to skew Abbott heart failure monitor study results

    The clinical trial of the CardioMEMS implantable sensor in a wider patient population missed its primary goal, but the company is moving forward based on an analysis adjusted for the pandemic.

    By Aug. 30, 2021
  • Abbott Laboratories
    Image attribution tooltip
    Courtesy of Abbott

    Abbott's Amulet trial results could lift LAA closure market: analysts

    Wall Street analysts were not surprised by the results given the recent FDA approval for Amulet, but agreed that the data was strong enough to boost the left atrial appendage closure products from Abbott and Boston Scientific.

    By Updated Aug. 31, 2021
  • 'Evidence gaps' spur CMS to call meeting to discuss cerebrovascular devices

    The agency said the "shorter term data with greater reliance upon intermediate and surrogate outcomes" used to bring devices to market is "generally less helpful" for its assessments.

    By Aug. 11, 2021
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    Sarah Silbiger via Getty Images

    TransMedics stock halted in Nasdaq trading ahead of FDA advisory panel meeting

    The company's stock price was down more than 5% at the close of trading on Tuesday. An FDA panel on Wednesday is evaluating data concerning the safety and effectiveness of TransMedics' device for preserving donor livers.

    By Updated July 14, 2021
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    Danielle Ternes/MedTech Dive, original photo courtesy of Dexcom
    Q&A

    Dexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum

    Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.

    By July 6, 2021
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    Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom

    Roundup: Trial results, looming product releases fuel diabetes tech competition

    In the first half of the year, the space is meeting Wall Street's high expectations for 2021. Here's a roundup of MedTech Dive's coverage of the market, including from this week's American Diabetes Association meeting.

    June 30, 2021
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    Robotic Surgery/MedTech Dive

    Robotic abdominal surgery has no advantage over open, laparoscopic surgeries: meta-analysis

    The review found of 39 studies reporting surgical complications, just 10% showed fewer complications with robot-assisted surgery. The analysis was published in the Annals of Internal Medicine.

    By June 29, 2021
  • Medtronic smart insulin pen improved time in target blood glucose levels: study

    The medtech giant's trial results come as competition in the space is intensifying. Eli Lilly and Bigfoot Biomedical, partnered with Abbott, are also prioritizing the technology.

    By June 29, 2021
  • FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset

    The trial results show improved health outcomes in a crucial patient population for the company: individuals requiring multiple daily injections of insulin.

    By June 28, 2021