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

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