Research: Page 2

Analysis of FDA safety alerts spurs call for changes to medical device adverse event reporting

Slow implementation of UDI and NEST are among the hangups prompting JAMA Internal Medicine authors to envision a better U.S. system for tracking and identifying adverse events, including more mandatory reporting.

By Nick Paul Taylor • Sept. 30, 2020

Dexcom takes another step to keep CGMs in hospitals while Abbott targets athletes

By amassing early evidence in untapped populations, the companies hope to pursue lucrative new parts of the U.S. market.

By Maria Rachal • Sept. 18, 2020

Smartwatch EKGs could speed diagnosis of deadly heart syndrome, small study suggests

Some medical groups have questioned the use of wearables like the Apple Watch to detect certain conditions, but authors writing in JAMA Cardiology said they may be useful when an electrocardiogram is not available.

By Susan Kelly • Sept. 01, 2020

ER visits lag behind in hospital volume recovery

A survey of more than 500 U.S. hospitals shows ER visits were down 25% compared to pre-pandemic levels for the 3.5 months leading up to June 21.

By Shannon Muchmore • July 15, 2020

Q&A

Q&A: New NESTcc chief on the real-world evidence group's 'pivot point' and COVID-19

Sandra Siami, the new head of the National Evaluation System for health Technology Coordinating Center, says the pandemic's limitations on traditional clinical studies have put alternative sources of device data in the limelight.

By Maria Rachal • June 29, 2020

NIH loops Quest into effort to test 10K Americans for antibodies against coronavirus

The agency did not disclose which antibody test it will use as part of the All of Us initiative, saying only that the assay has FDA emergency use authorization and is designed to detect IgG antibodies. 

By Nick Paul Taylor • June 17, 2020

Key data on Medtronic's 780G, Insulet's Horizon kick off ADA 2020

Abbott, Dexcom and Tandem will also present results at the virtual American Diabetes Association meeting that runs through Tuesday.

By Maria Rachal • June 12, 2020

Cardiology group ranks best devices for aorto-iliac arterial interventions

The Society for Cardiovascular Angiography and Interventions detailed stances on several key issues, including endovascular device effectiveness, issued Thursday at its virtual conference.

By Nick Paul Taylor • May 15, 2020

Ventilator sharing among states critical to save COVID-19 patient lives: Health Affairs paper

Without a coordinated federal effort to promote the exchange of the breathing assist machines, thousands more Americans will die in the coming weeks as the virus continues its rampage across the U.S., a new paper warns.

By Susan Kelly • May 04, 2020

Study questions TAVR access disparities under new CMS coverage policy

The number of hospitals offering the less invasive aortic valve disease treatment could double under Medicare's revised coverage, but limited access in rural and safety net hospitals appears likely to persist, according to research.

By Susan Kelly • April 07, 2020

High-risk devices with expedited reviews more likely to be recalled, research suggests

As FDA's Breakthrough Devices Program rises in popularity, a JAMA Internal Medicine analysis found almost two-thirds of Class III devices approved with priority review status between 2005 and 2015 were recalled.

By Nick Paul Taylor • March 31, 2020

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