Clinical Trials: Page 15
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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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Deep Dive
Pharma and AI? Let's try augmented intelligence first
Pharma will need collaborations and in-house capabilities to successfully use AI across drug development.
By Lisa LaMotta • July 23, 2018 -
NIH center makes public a trove of CT images for research
Named DeepLesion, the collection contains CT images of more than 32,000 lesions from across the body, ranging from lung nodules to liver tumors.
By Susan Kelly • July 23, 2018 -
Tendyne investors sue Abbott over lost milestone payment
After the success of transcatheter aortic valve replacement therapy, device companies are now focusing efforts on minimally invasive procedures to replace the mitral valve.
By Susan Kelly • July 23, 2018 -
FDA finalizes guidance on use of EHRs in clinical trials
Industry groups including AdvaMed and BIO were broadly supportive of an earlier draft.
By Nick Paul Taylor • July 19, 2018 -
HHS kills clinical guidelines website, cites budget cuts
The National Guideline Clearinghouse, a 20-year-old archive of best medical practices, was shut down this week. On Tuesday, the nonprofit that maintained the site said it will keep a fee-based version to launch in the fall.
By Rebecca Pifer • July 17, 2018 -
Biogen looking to expand into medtech: report
The biotech is considering how imaging and data technologies could bolster its position in neurology, according to the Israeli paper Globes.
By Lisa LaMotta • July 16, 2018 -
Gottlieb: Investment into leveraging RWD will benefit device, drug safety
Allowing FDA to use de-identified EHR clinical medical information would boost safety monitoring and shift more development to a post-market setting, the FDA commissioner said.
By David Lim • July 11, 2018 -
Wearable ECG patch increases atrial fibrillation diagnosis in clinical trial
Use of a digital health device has increased diagnosis of atrial fibrillation, raising hopes that stroke risk can be reduced.
By Nick Paul Taylor • July 11, 2018
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