Clinical Trials: Page 13
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FDA outlines fast track vision for breakthrough devices
The agency also announced plans to establish a pathway for devices aimed at treating non-life-threatening diseases not eligible for the original program.
By David Lim • Dec. 18, 2018 -
Novartis, Pear move digital schizophrenia drug into Phase 2
The trial will assess whether behavior therapy software can improve the symptoms of people with schizophrenia.
By Nick Paul Taylor • Dec. 18, 2018 -
BioSig partners with Mayo Clinic for electrophysiology recording system trial
BioSig thinks the technology improves on systems sold by companies like Abbott and Boston Scientific.
By Nick Paul Taylor • Dec. 7, 2018 -
Patient perspective missing in device clinical trials, FDA says
Studies of medical devices have struggled to recruit and retain participants and meaningfully communicate findings to patients, prompting FDA to seek feedback for a draft guidance on developing better patient-centered studies.
By Maria Rachal • Nov. 27, 2018 -
Vectura asthma drug-device combo fails in Phase 3 study
As a result, the pharma will abandon VR475 but carry on with another candidate and three early-stage nebulization programs.
By Andrew Dunn • Nov. 26, 2018 -
CMS gives mixed ruling on LivaNova depression device
A big market opportunity awaits the U.K. device maker if Medicare moves to cover the vagus nerve stimulation device for hard-to-treat depression after a required clinical trial.
By Maria Rachal • Nov. 21, 2018 -
Cardiva's vascular closure system cuts patient recovery times in study
The findings precede an anticipated FDA decision on a premarket approval application for the company's system for multi-vessel closure.
By Nick Paul Taylor • Nov. 13, 2018 -
BD posts long-awaited clinical data on Lutonix balloon in CLI
If the approval and commercialization go to plan, BD thinks the below-the-knee opportunity is worth about $250 million a year.
By Nick Paul Taylor • Nov. 8, 2018 -
Genentech releases more data on refillable eye implant
Study results showed that vision and anatomical outcomes in wet AMD patients who received the device, and dosed every six months or longer, were comparable to ranibizumab dosed every four weeks.
By Susan Kelly • Oct. 30, 2018 -
Myriad's BRCA test supports successful ovarian cancer trial
The molecular diagnostics company plans to file to expand use of the genetic test.
By Nick Paul Taylor • Oct. 23, 2018 -
Abbott medical device, diagnostic units drive Q3 growth
CEO Miles White said Abbott plans to submit its data to FDA in the coming weeks to back an expanded indication for MitraClip.
By David Lim • Oct. 17, 2018 -
Deep Dive
FDA 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 -
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 -
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 -
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 -
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