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

Insulet's pivotal study back on track, setting up Horizon launch in early 2021

The diabetes device maker fixed a software glitch it found with the smartphone-controlled automated insulin delivery system three months ago. Abbott and Dexcom plan to make their CGM tech compatible with the system.

By Maria Rachal • June 5, 2020

JAMA reanalysis goes against 5-year Abbott stent study findings, upping odds of death

The JAMA Internal Medicine report raised doubts about the claim percutaneous coronary intervention is noninferior to bypass surgery and fueled a call for changes to guidelines.

By Nick Paul Taylor • June 3, 2020

Many heart device trials 'small and fragile,' come with misleading spin: JAMA study

A JAMA Internal Medicine review of 216 trials of invasive cardiovascular interventions also found commercial sponsor involvement linked to more distortion or misrepresentation of the data.

By Nick Paul Taylor • June 2, 2020

Investors bet diabetes tech immune to full brunt of COVID-19

Pure play diabetes device makers aren't clear yet on how economic uncertainty and the transition to telemedicine may affect new patient demand, but are outperforming the stock market by a long shot.

By Maria Rachal • May 19, 2020

Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves

A decade of data on the Melody valve found it more effective in adults than in pediatric patients. In a separate study, the in-development Harmony valve designed to treat severe pulmonary regurgitation met its primary endpoints.

By Susan Kelly • May 18, 2020

EC outlines clinical trial safety reporting between MDR, Eudamed start dates

Even with the recent delay to the date of application of the Medical Device Regulation, there will still be at least a 12-month period when the key Eudamed database is not fully available.

By Nick Paul Taylor • May 14, 2020

AtriCure treatment for persistent AFib shows superiority in study

The ablation procedure met study goals among patients with hard-to-treat forms of the heart rhythm disorder, which analysts say put it on track for FDA approval to address a market worth at least $1 billion.

By Susan Kelly • May 11, 2020

Thrive, chasing Grail with a cancer blood test, finds tumors in seemingly healthy women

A first-of-its-kind trial of 10,000 women supported the test's potential to catch some cancers early. But whether it can truly help people is not entirely clear.

By Ben Fidler • April 28, 2020

Novocure shares data from post-approval brain cancer device trial

As part of the virtual AACR 2020, researchers said data show use of a Novocure technology resulted in longer median overall survival than occurred with best standard of care chemotherapy.

By Nick Paul Taylor • April 28, 2020

Stenting matches bypass surgery in 10-year study of left main patients

The similar rates of mortality and major cardiac or cerebrovascular adverse events may be positive for drug-eluting stent makers such as Abbott and Boston Scientific.

By Nick Paul Taylor • March 31, 2020

Low-risk TAVR: Edwards results taper in 2nd year, Medtronic targets bicuspid market

The companies again looked to expand use of the procedure a year after presenting pivotal data at the American College of Cardiology meeting on the low-risk population, but results were less emphatic.

By Nick Paul Taylor • March 30, 2020

Medtronic's renal denervation system shows it can lower blood pressure

Results presented at the American College of Cardiology's virtual meeting come after a big setback in 2014 when the device failed to show effectiveness. 

By Susan Kelly • March 30, 2020

Insulet pauses automated dosing system trial amid software glitch

The delay will likely push back a U.S. product launch of the diabetes technology until early 2021. Also Monday, competitor Tandem said it won its second FDA designation for an interoperable automated glycemic controller.

By Maria Rachal • March 2, 2020

LivaNova loops Verily into depression device study

A clinical trial meant to support CMS coverage of the U.K. medtech's vagus nerve stimulation system will incorporate a wearable device and phone app from Alphabet's life sciences research organization.

By Maria Rachal • Feb. 27, 2020

Medtronic faces key test in establishing US market for renal denervation

After a setback six years ago, the medtech giant is set to unveil pivotal trial data next month on a procedure to lower blood pressure. Abbott and Boston Scientific are likely watching closely.

By Susan Kelly • Feb. 10, 2020

Abiomed, on defense, plans wave of trials to counter Impella criticism

The maker of the heart pump is seeking to quash doubts after two large observational studies suggested the product was more risky and pricey than alternative treatments.

By Nick Paul Taylor • Feb. 6, 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

Abiomed device controversy revived in Circulation editorial

Experts flagged key limitations in a study suggesting the Impella device is pricier and more dangerous than intra-aortic balloon pumps, and highlighted an "urgent need" for randomized clinical trials.

By Nick Paul Taylor • Jan. 29, 2020

After subdued year for new spinal cord stim tech, industry seeks 2020 rebound

Medtronic, Abbott, Boston Scientific and others that presented at the North American Neuromodulation Society meeting hope an influx in new products will help restore market growth.

By Maria Rachal • Jan. 27, 2020

Study of Abbott's HeartMate 3 points to single treatment indication for LVADs

A study in JAMA Cardiology suggests it's unnecessary to group heart failure patients by transplant eligibility, which one cardiologist said could allow physicians to sidestep difficult upfront decisions about transplants and pumps.

By Nick Paul Taylor • Jan. 16, 2020

FDA OKs Abbott clinical trial of MitraClip in moderate risk patients

The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery. 

By David Lim • Jan. 13, 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. 9, 2020

The MedTech Dive Awards of 2019

From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.

Dec. 9, 2019

Boston Scientific afib device effective in reducing stroke

Authors in the Journal of the American College of Cardiology said the rate of hemorrhagic stroke observed in left atrial appendage closure device registries is the lowest identified in the nonvalvular atrial fibrillation population.

By Nick Paul Taylor • Dec. 5, 2019