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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

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