Research

Blood test to detect breast cancer recurrence, guide treatment, shows promise in small study

Researchers hope the liquid biopsy test, which demonstrated high accuracy in detecting residual disease in a small study, can help breast cancer patients avoid unnecessary surgeries.
By Susan Kelly • Aug. 12, 2019
Apple, Eli Lilly research whether devices can detect dementia signs

The two companies, along with health tech startup Evidation, found promising initial results but concluded additional research is needed.
By Rebecca Pifer • Aug. 08, 2019
FDA to update paclitaxel device labels with mortality signal warning

The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.
By David Lim • UPDATED: Aug. 8, 2019 at 10:08 a.m.
Cardiac device complications vary 'substantially' by implanting hospital, study finds

The analysis of 98 hospitals, published this week in the Annals of Internal Medicine, uncovered an up-to-threefold difference in cardiac implant complication rates.
By Nick Paul Taylor • Aug. 01, 2019
Mayo, Boston Scientific deepen ties with medtech accelerator launch

The joint venture, called Motion Medical, is expected to open in Rochester, Minnesota this fall with the purpose of bringing minimally invasive treatments to market for unmet health needs.
By Susan Kelly • July 30, 2019
Edwards discontinues Centera valve, goes all in on Sapien 3 TAVR line

Executives said the company anticipates FDA will approve the transcatheter aortic valve replacement product for patients with low surgical risk during the third quarter.
By David Lim • July 24, 2019
PCORI, MD Anderson team up on lung cancer screening aid

Funded by the Patient-Centered Outcomes Research Institute, the project targets high-risk smokers for lung cancer screening. A second program looks to expand care for adolescents with behavior problems after traumatic brain injury.
By Susan Kelly • July 24, 2019
Random plasma glucose testing helps predict diabetes in large VA study

Department of Veterans Affairs researchers combing data from nearly 1 million patients found routine blood tests to be an overlooked but effective means of identifying patients at risk of developing the disease within five years.
By Susan Kelly • July 22, 2019
Fertility apps hold promise, but less precise than conventional methods, study finds

A Nature journal analysis of data captured by the Kindara and Sympto apps led independent researchers to predict self-tracked results will support the quantification of infertility or daily pregnancy chances.
By Nick Paul Taylor • July 19, 2019
FDA launches innovation challenge to boost ethylene oxide sterilization alternatives

The agency also plans to hold an advisory committee meeting Nov. 6-7 to discuss how to further encourage innovations in medical device sterilization.
By David Lim • July 16, 2019
Screenings fail to explain rise in colorectal cancer in younger adults, study finds

The American Cancer Society called for further study of the trend, saying factors beyond expanded use of colonoscopy testing may play a role in driving the increased incidence of colorectal cancer.
By Susan Kelly • July 15, 2019
FDA qualifies tool for nonclinical testing of ultrasound devices

The tool features a material designed to mimic the behavior of tissue to enable companies to assess and improve the safety of devices.
By Nick Paul Taylor • July 12, 2019
Boston Scientific says Watchman more cost effective than drugs for AFib

In the Journal of the American Heart Association, researchers examined long-term data pooled from the Protect AF and Prevail clinical trials of the company's Watchman device for stroke prevention in atrial fibrillation patients.
By Susan Kelly • July 01, 2019
MRI as safe as cardiac catheterization for coronary disease screening: NEJM

The study's author hopes less-invasive MRI scans will become more widely used for making treatment decisions for patients with stable chest pain, reducing the need for cardiac catheterization.
By Susan Kelly • June 25, 2019
Roche assay identifies Alzheimer's biomarker in blood samples

The assay predicted beta-amyloid status but fell short of being accurate enough to independently confirm the presence of the biomarker, according to research published in JAMA Neurology.
By Nick Paul Taylor • June 25, 2019
Yale researchers predict 3D mammography to become standard of care

Use of digital breast tomosynthesis in breast cancer screenings jumped about 30% in the U.S. between 2015 and 2017, according to an analysis published Monday in JAMA Internal Medicine.
By Maria Rachal • June 24, 2019
Label should warn patients of paclitaxel device mortality signal, FDA panel says

The advisory committee struggled through the two-day meeting evaluating the safety of the devices due to incomplete data. Members agreed more data is needed but differed on the method the agency should use to collect it.
By David Lim • June 21, 2019
Inhaler monitoring lowers COPD hospitalizations in small study

Cleveland Clinic researchers found that use of electronic inhaler monitoring together with a disease management program reduced healthcare utilization.
By Susan Kelly • June 12, 2019
Harvard's Wyss Institute receives $131M gift

The contribution comes from founder Hansjörg Wyss, the former CEO of Swiss device maker Synthes, whose vision for the institute has led to several medical breakthroughs over the past decade.
By Susan Kelly • June 10, 2019
Thermo Fisher buys mass spec software partner HighChem

HighChem, which has worked with Thermo Fisher for 20 years, lists Pfizer, Roche and Sanofi among its customers.
By Nick Paul Taylor • June 07, 2019
Muscle relaxation app helps calm migraine in small NYU study

Migraine sufferers who used the smartphone app at least twice a week had four fewer headache days per month on average.
By Susan Kelly • June 05, 2019
Verily creates machine learning tool to aid diagnostic development

DeepMass expanded the coverage of known biomarkers when applied to clinical data.
By Nick Paul Taylor • May 29, 2019
Abbott releases 30-day data on tricuspid valve repair system

The late-breaking study results released at the EuroPCR meeting in Paris showed the investigational device reduced tricuspid regurgitation at 30 days.
By Susan Kelly • May 22, 2019
Real-world operations: NESTcc director on building a business and the future of device evaluation

The National Evaluation System for health Technology and its real-world evidence projects are finally getting off the ground. Now the center needs to secure industry's buy-in, said Rachael Fleurence, executive director.
By Maria Rachal • May 20, 2019
Abbott, NIH collaborate on neuroscience research

The company will contribute its neuromodulation technologies to the National Institutes of Health's work on brain disorders.
By Susan Kelly • May 15, 2019