Research

Joint FDA, industry real-world evidence center issues research frameworks

As real-world evidence gains momentum as a tool for assessing medical device safety and effectiveness, NESTcc is laying out guiding principles on research methods and ensuring data quality.

By Amritpal Sandhu-Longoria • Feb. 27, 2020

Analysis casts doubt on Boston Scientific TAVR embolic protection device

The JAMA Internal Medicine research rekindles debate over whether the device, designed to catch dislodged plaque debris in the carotid arteries before it reaches the brain, is truly effective.

By Susan Kelly • UPDATED: Feb. 25, 2020 at 3 p.m.

Wearable heart rate sensor accuracy didn't vary across skin tones in small Duke study

But data from 53 individuals, published Monday, revealed differences in accuracy by device manufacturer across activity type.

By Susan Kelly • Feb. 11, 2020

Renewed calls for Impella RCT as JAMA details bleeding, death rate findings

Abiomed has cast doubt on the registry-based study, though some cardiologists argue it supports “a more restrictive use” of the circulatory support device.

By Nick Paul Taylor • Feb. 11, 2020

5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common

Separately, a pair of cardiologists in an editorial published this week in the journal Circulation noted potential "important differences" between Edwards' Sapien 3 and Medtronic’s CoreValve devices.​

By Nick Paul Taylor , Maria Rachal • Jan. 30, 2020

Robotic surgeries surge to 15% of all procedures, despite limited evidence

Robot-assisted procedures jumped from accounting for 1.8% of all general surgeries in 2012 to 15.1% in 2018. Closer monitoring is needed to ensure clinical benefits and safety are prioritized, researchers said.

By Susan Kelly • Jan. 14, 2020

Study links paclitaxel devices to better survival in PAD, muddying debate

New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.

By David Lim • Jan. 09, 2020

Pulmonary hypertension common in MitraClip patients, increasing mortality risk: JAMA Cardiology

After reviewing more than 4,000 cases of mitral valve repair, researchers proposed exploring intervention with devices like Abbott's MitraClip earlier in disease progression to improve outcomes.

By Nick Paul Taylor • Nov. 21, 2019

Abiomed's Impella may be associated with higher costs, more adverse events than balloon therapy, studies find

"In the long term, who knows how this will play out?" Jefferies analyst Raj Denhoy told MedTech Dive Monday morning amid a 10% drop in its share price. "In terms of the stock, it isn't great." 

By Dana Elfin • Nov. 18, 2019

FDA advisers: Metal implants need beefed up ingredient labels

Industry representative Whitney Christian, a toxicologist at Medtronic, told the panel that medical device manufacturers support patients' and doctors' "right to know" what's in implants and are willing to work with FDA on the issue. 

By Maria Rachal • Nov. 15, 2019

Landmark Apple Watch AFib study has mixed results

Researchers touted an apparent low incidence of false positives, but many who didn't receive a notification were subsequently diagnosed with atrial fibrillation, according to research published in the New England Journal of Medicine.

By David Lim • Nov. 14, 2019

FDA experts weigh evidence on patients' adverse reactions to common device metals

Suggestions from speakers at Wednesday's advisory panel included conducting comparative effectiveness studies, bolstering the informed consent process and requiring more stringent adverse event reporting.

By Maria Rachal • Nov. 13, 2019

Sponsored by ZS

New product launches: Some matter more than others

Answering two simple questions can enable medtech companies to both prioritize launches and determine the right approach for each launch.

By Matt Singer • Nov. 05, 2019

Researchers question safety benefit of robotic colectomies

Despite a sharp rise in robot-assisted colon removal procedures using devices like Intuitive Surgical's da Vinci system, research published in JAMA Surgery found a laparoscopic approach has a comparable rate of complications. 

By Nick Paul Taylor • Oct. 17, 2019

Sponsored by ZS

Streamlining your portfolio can actually improve profitability. Here's how.

Retiring products is not an easy decision, but taking this step can have a real and positive impact on the P&L, customer, cross-functional teams and the ability to drive innovation. 

By Matt Singer • Oct. 08, 2019

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