Clinical Trials: Page 12


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    BioPharma Dive
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    Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women

    A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. But whether it can truly help people is not entirely clear.

    By Ben Fidler • April 28, 2020
  • Novocure shares data from post-approval brain cancer device trial

    As part of the virtual AACR 2020, researchers said data show use of a Novocure technology resulted in longer median overall survival than occurred with best standard of care chemotherapy.

    By April 28, 2020
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • Stenting matches bypass surgery in 10-year study of left main patients

    The similar rates of mortality and major cardiac or cerebrovascular adverse events may be positive for drug-eluting stent makers such as Abbott and Boston Scientific.

    By March 31, 2020
  • Low-risk TAVR: Edwards results taper in 2nd year, Medtronic targets bicuspid market

    The companies again looked to expand use of the procedure a year after presenting pivotal data at the American College of Cardiology meeting on the low-risk population, but results were less emphatic.

    By March 30, 2020
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    Medtronic
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    Medtronic's renal denervation system shows it can lower blood pressure

    Results presented at the American College of Cardiology's virtual meeting come after a big setback in 2014 when the device failed to show effectiveness. 

    By March 30, 2020
  • Insulet pauses automated dosing system trial amid software glitch

    The delay will likely push back a U.S. product launch of the diabetes technology until early 2021. Also Monday, competitor Tandem said it won its second FDA designation for an interoperable automated glycemic controller.

    By Maria Rachal • March 2, 2020
  • LivaNova loops Verily into depression device study

    A clinical trial meant to support CMS coverage of the U.K. medtech's vagus nerve stimulation system will incorporate a wearable device and phone app from Alphabet's life sciences research organization.

    By Maria Rachal • Feb. 27, 2020
  • Medtronic faces key test in establishing US market for renal denervation

    After a setback six years ago, the medtech giant is set to unveil pivotal trial data next month on a procedure to lower blood pressure. Abbott and Boston Scientific are likely watching closely.

    By Feb. 10, 2020
  • Abiomed, on defense, plans wave of trials to counter Impella criticism

    The maker of the heart pump is seeking to quash doubts after two large observational studies suggested the product was more risky and pricey than alternative treatments.

    By Feb. 6, 2020
  • 5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common

    Separately, a pair of cardiologists in an editorial published this week in the journal Circulation noted potential "important differences" between Edwards' Sapien 3 and Medtronic’s CoreValve devices.​

    By , Maria Rachal • Jan. 30, 2020
  • Abiomed device controversy revived in Circulation editorial

    Experts flagged key limitations in a study suggesting the Impella device is pricier and more dangerous than intra-aortic balloon pumps, and highlighted an "urgent need" for randomized clinical trials.

    By Jan. 29, 2020
  • After subdued year for new spinal cord stim tech, industry seeks 2020 rebound

    Medtronic, Abbott, Boston Scientific and others that presented at the North American Neuromodulation Society meeting hope an influx in new products will help restore market growth.

    By Maria Rachal • Jan. 27, 2020
  • Study of Abbott's HeartMate 3 points to single treatment indication for LVADs

    A study in JAMA Cardiology suggests it's unnecessary to group heart failure patients by transplant eligibility, which one cardiologist said could allow physicians to sidestep difficult upfront decisions about transplants and pumps.

    By Jan. 16, 2020
  • FDA OKs Abbott clinical trial of MitraClip in moderate risk patients

    The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery. 

    By David Lim • Jan. 13, 2020
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    Study links paclitaxel devices to better survival in PAD, muddying debate

    New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.

    By David Lim • Jan. 9, 2020
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    Kendall Davis/MedTech Dive
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    Dive Awards

    The MedTech Dive Awards of 2019

    From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.

    Dec. 9, 2019
  • Boston Scientific afib device effective in reducing stroke

    Authors in the Journal of the American College of Cardiology said the rate of hemorrhagic stroke observed in left atrial appendage closure device registries is the lowest identified in the nonvalvular atrial fibrillation population.

    By Dec. 5, 2019
  • MRI screening linked to improved detection of breast cancer

    The New England Journal of Medicine study found fewer cases of cancer are missed when MRIs are performed. At the same time, the scans come with a high rate of false positives, calling the utility of additional imaging into question.

    By Dec. 2, 2019
  • In stents v. statin debate, analysts call potential impact of ISCHEMIA trial overhyped

    The study seemed to favor a conservative approach to treating stable heart disease. But many sell-side analysts called results expected, predicting they won't meaningfully hurt sales for device makers like Boston Scientific.

    By Maria Rachal • Nov. 18, 2019
  • J&J reports rising success rate in robotic surgery clinical trial

    The study is assessing diagnostic abilities of the Monarch robotic surgery platform, which Johnson & Johnson gained in the $3.4 billion acquisition of Auris Health.

    By Oct. 24, 2019
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    Jacob Bell
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    Experimental cancer IVD trial guidance finalized

    AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.

    By Oct. 10, 2019
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    Nasdaq
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    Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down

    The company is "disappointed" the steroid delivery device, which it hopes to submit for premarket approval to FDA, did not prove superior on frontal sinus patency at 30 days when randomized against an uncoated balloon.

    By Maria Rachal • Oct. 7, 2019
  • Edwards shows improved quality of life, durability of TAVR systems in trio of studies

    Among other data presented over the weekend at TCT, Boston Scientific's in-development Acurate Neo TAVR system failed to meet a non-inferiority goal on safety and efficacy when compared to Edwards' Sapien 3.

    By Sept. 30, 2019
  • Abbott's MitraClip outperforms medical therapy in study at 3 years

    In addition, a group of patients that began the study on medical therapy and crossed over to the MitraClip at two years saw benefits matching those who received the device from the start.

    By Sept. 30, 2019
  • Medtronic, Boston Scientific share data on stents with short-course antiplatelet therapy

    The clinical trials provide data supporting the use of shorter regimens in coronary stent patients.

    By Sept. 27, 2019