Clinical Trials: Page 14
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Deep DiveFDA takes aim at lack of pediatric devices
"Funding is a huge challenge because of the inherently small market," Reed McCarty, co-founder and partner at SandBox Medical, told MedTech Dive.
By Meg Bryant • Oct. 8, 2018 -
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Prostate cancer imaging agent meets one of two study endpoints
The results mark Progenics Pharmaceuticals' second clinical trial for a prostate cancer imaging agent to show mixed results in as many months.
By Susan Kelly • Oct. 8, 2018 -
Karius posts clinical data on heart infection test
The test identified the pathogen affecting one of the three patients failed by traditional methods.
By Nick Paul Taylor • Oct. 5, 2018 -
AdvaMed
5 themes from The MedTech Conference
Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.
By David Lim , Kim Dixon • Oct. 1, 2018 -
Medtronic CoreValve proves durable in longer-term data
Severe hemodynamic structural valve deterioration was 0.8% for CoreValve versus 1.8% for surgery across five years, with similar rates of mortality and major stroke in both patient samples.
By Susan Kelly • Sept. 25, 2018 -
Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study
Results of the first head-to-head clinical trial to compare the two drug-eluting stents to treat leg artery blockages were presented at a scientific meeting this weekend. On Monday, the FDA cleared the Boston device.
By Susan Kelly • Sept. 24, 2018 -
Medtronic heart stent works as well as thin-strut Orsiro: study
The device giant's Resolute Onyx coronary stent was found to be as effective and safe as the Orsiro ultra-thin-strut stent made by privately held Berlin-based Biotronik.
By Susan Kelly • Sept. 24, 2018 -
Abbott's MitraClip keeps more heart valve patients alive in study
The device for minimally invasive repair of the mitral heart valve in patients with advanced heart failure and severe mitral regurgitation significantly reduced both hospitalizations and mortality.
By Susan Kelly • Sept. 24, 2018 -
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Medtronic to study TAVR in low-risk bicuspid patients
FDA also approved a revised label for the Evolut valve that removes a precaution for patients with aortic stenosis at intermediate or greater mortality risk from surgical aortic valve replacement.
By Susan Kelly • Sept. 19, 2018 -
Adobe Stock
Medtronic to study one month of DAPT in high-bleeding-risk patients
The study will look at whether a shortened dual antiplatelet therapy regimen is enough to minimize stent thrombosis and other complications in patients.
By Susan Kelly • Sept. 11, 2018 -
Wikimedia
BTG acquires Irish device maker Novate Medical
The $20 million cash deal could reach $150 million if certain business milestones are met.
By David Lim • Sept. 7, 2018 -
Lilly's tau PET tracer hits goals in late-phase trial
Results suggest flortaucipir F18 can predict brain tau pathology and Alzheimer's diagnosis. J&J, Merck & Co. and Roche are working on rivals.
By Nick Paul Taylor • Sept. 6, 2018 -
Medtronic cryoballoon reduces persistent afib symptoms in study
The ablation device uses cold energy to interrupt irregular electrical signals in the heart in a minimally invasive procedure.
By Susan Kelly • Aug. 31, 2018 -
Credit: Andrew Propp, FDA / Edited by BioPharma Dive
Gottlieb hails early breakthrough device successes, plans AI benchmarks
The commissioner set out how the FDA is accelerating the development of medical devices.
By Nick Paul Taylor • Aug. 30, 2018 -
Adobe Stock
Balloons as effective as stents to open small arteries, study says
The study is the largest randomized trial to look at whether drug-coated balloons are as effective as drug-eluting stents, according to the researchers.
By Susan Kelly • Aug. 29, 2018 -
NIH-backed trial links device to drop in cardiac arrest deaths
The study found patients were more likely to survive after treatment with laryngeal tubes.
By Nick Paul Taylor • Aug. 29, 2018 -
IDx publishes AI test data that supported landmark approval
The company sees the diagnostic as a useful tool enabling primary care physicians to screen for diabetic retinopathy.
By Nick Paul Taylor • Aug. 29, 2018 -
Medication reminder apps for heart patients could save lives, study says
The American Heart Association says an estimated three out of four Americans do not take their medication as directed.
By Susan Kelly • Aug. 28, 2018 -
Getty Images
Doctors often fail to list conflicts in device studies: JAMA report
Doctors got the highest payouts from Medtronic, which accounted for more than $187.4 million, followed by Stryker and Intuitive Surgical, according to a JAMA analysis.
By Susan Kelly • Aug. 20, 2018 -
Adobe Stock
Early A1C test may reduce gestational diabetes risk: NIH study
The NIH researchers analyzed records from the NICHD Fetal Growth Study of more than 2,000 low-risk pregnant women from 12 U.S. clinical sites between 2009 and 2013.
By Susan Kelly • Aug. 17, 2018 -
AdvaMed pushes back against FDA humanitarian device guidance
The trade group thinks the guidance will deter development of devices to treat rare conditions.
By Nick Paul Taylor • Aug. 15, 2018 -
Jacob Bell
FDA sets out vision to use real-world data in product evaluations
The agency wants insights into safety and efficacy outside of controlled research environments.
By Nick Paul Taylor • Aug. 14, 2018 -
Medtronic begins study of ICD with leads outside the heart
The device, called the Extravascular Implantable Cardioverter Defibrillator, will provide the same therapies as traditional transvenous ICDs.
By Susan Kelly • Aug. 10, 2018 -
Gettty / edited by Industry Dive
Anthem, doc.ai to test blockchain-enabled AI to predict allergies
Doc.ai's end-to-end platform includes trial recruitment, engagement, data collection and predictive models.
By Meg Bryant • Aug. 2, 2018 -
FDA approves Medtronic implant for rare form of hypertension
United Therapeutics will lead commercial promotion of the system, which delivers the drug Remodulin.
By Susan Kelly • Aug. 1, 2018
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