Clinical Trials: Page 3


  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    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 Ricky Zipp • 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.
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    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
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    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
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    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 Ricky Zipp • 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 Ricky Zipp • 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
  • Nevro's painful diabetic neuropathy data marred by disappointing Q2 forecast

    CEO Keith Grossman said he's "frankly disappointed" at the pace of the recovery, suggesting the company may miss its sales target. Shares were down nearly 6% Monday morning.

    By June 28, 2021
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell / BioPharma Dive

    Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval

    The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.

    By Jacob Bell • June 16, 2021
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    Sarah Silbiger via Getty Images

    FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

    The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

    By June 14, 2021
  • Nick Jonas, Dexcom
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    Courtesy of Dexcom, Nick Jonas Super Bowl kit

    Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott

    The results compare favorably to data on Abbott’s Libre 2, further setting the stage for the release of one of the most anticipated new products of 2021 in the diabetes tech market.

    By June 4, 2021
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    Ewa Krawczyk, National Cancer Institute

    An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

    Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it. 

    By Ben Fidler • June 3, 2021
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    National Cancer Institute, NIH

    In first, FDA approves KRAS-blocking cancer drug from Amgen

    After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.

    By Ned Pagliarulo • Updated May 29, 2021
  • A building in front of a lake with the words 'Medtronic' on a sign.
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    Medtronic

    Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial

    The medtech giant seeks to double or triple sales in its 2023 fiscal year. However, analysts warned that near-term investments will pressure margins in the short term.

    By May 28, 2021
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    Sarah Silbiger via Getty Images

    FDA draft guidances lay out postmarket medical device data requirements

    Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs. 

    By May 27, 2021
  • Edwards tricuspid valve replacement cut leakage for 98% of participants in early trial results

    A total of 56 patients were examined 30 days after a transcatheter tricuspid valve replacement procedure. Edwards now plans to start a pivotal trial, examining the procedure in 775 patients.

    By Ricky Zipp • May 17, 2021
  • Edwards withstands winter lows, grows Q1 sales on electives recovery

    CEO Michael Mussallem said volumes grew gradually through March after a significant drop, continuing the early trend of procedure-dependent medtechs reporting a return of non-emergency procedures.

    By Ricky Zipp • April 21, 2021
  • A building in front of a lake with the words 'Medtronic' on a sign.
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    Medtronic

    FDA puts Medtronic Valiant Navion stent graft recall in Class I category

    The action, which comes amid one patient death in a clinical trial, deprives Medtronic of a source of sales growth. After securing 2018 approval, then-CEO Omar Ishrak talked up the device's potential to drive incremental growth.

    By April 12, 2021
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    Permission granted by IQVIA

    FDA-medtech consortium offers strategy to boost patient engagement in clinical trials

    The MDIC report, created by a working group including Exact Sciences and J&J, follows the agency's late 2019 draft guidance meant to increase the influence of patients in medical device clinical trial design. 

    By April 7, 2021