Research: Page 2

Paclitaxel device makers roll out revised labels, fresh safety analyses

Philips and BD highlighted independent analyses published this week defending their drug-coated balloons as manufacturers update product labels acknowledging a late mortality signal in peripheral artery disease patients.

By Maria Rachal • Oct. 03, 2019

NESTcc, ophthalmic imaging first up in FDA medical device 'collaborative communities'

Creation of these groups of manufacturers, payers, regulators, patients and health professionals is one of the device center's 2018-2020 strategic priorities.

By David Lim • Sept. 20, 2019

Researchers use MRI technique to predict dementia risk

Authors of a study published in the journal Stroke said the imaging technique can help physicians monitor stroke patients and identify individuals who may benefit from early treatment.

By Nick Paul Taylor • Sept. 13, 2019

Brexit threatens UK robotic surgery innovation, study finds

The Imperial College London analysis indicates a hard split from the EU could cause the U.K. to lose collaborations with other member states.

By Nick Paul Taylor • Sept. 12, 2019

Apple to start trio of research studies on hearing, heart and women's health

The studies, which will be organized through a new Apple Research app this fall, are being conducted in partnership with various universities, hospitals, associations and the U.S. government.

By David Lim • Sept. 11, 2019

Abbott says AI technology can help diagnose heart attacks

A study in the journal Circulation concluded the algorithm, which aims to individualize testing by taking into account factors such as patient age and sex, performed better than the European Society of Cardiology rule-out pathway.

By Susan Kelly • Sept. 11, 2019

NESTcc 1.0 aims to launch, be able to take unsolicited projects by end of year

The National Evaluation System for health Technology Coordinating Center Task Force is also currently developing an active surveillance roadmap it aims to issue for public comment this fall.

By David Lim • Sept. 06, 2019

With partner iRhythm, Verily ramps up AFib efforts

iRhythm committed almost $18 million to Verily to boost development of technology that helps deliver earlier warnings to individuals with asymptomatic or silent atrial fibrillation.

By Maria Rachal • Sept. 05, 2019

Imaging test usage is reaccelerating, JAMA study finds

Neither financial incentives nor a campaign to reduce the use of medical imaging have been completely effective, research suggests.

By Susan Kelly • Sept. 04, 2019

Weight-loss surgery for Type 2 diabetes could cut major heart risks, study suggests

Published in JAMA and funded by Medtronic, results from the retrospective study have yet to be confirmed by randomized clinical trials.

By Maria Rachal • Sept. 03, 2019

Titan Medical delays 510(k) submission until 2020 amid cash burn concerns

The company plans to use the delay to spread out its spending while working to implement the robotic surgery system's sterile instrument interface components, software improvements and training tools.

By David Lim • Aug. 27, 2019

Abbott touts potential of 15-minute concussion detection

Highlighting research from the TRACK-TBI study, the company said its in-development point-of-care test could help diagnose concussion in patients whose CT scans miss signs of mild traumatic brain injury.

By Maria Rachal • Aug. 27, 2019

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