Abbott heart device for newborns shows longer-term benefits with three-year data

The trial results give Abbott more evidence as it seeks to position the product as an alternative to medical management or surgical ligation.

By Nick Paul Taylor • Sept. 8, 2022

Penumbra’s catheters achieve first-pass revascularization in 68.9% of stroke patients

A separate study found the device cleared clots in patients with tandem lesions, meeting the criteria for successful restoration of blood flow in 84% of subjects.

By Nick Paul Taylor • Aug. 26, 2022

Review finds ‘paucity of robust evidence’ on impact of AI clinical outcomes

Of the nearly 12,000 articles on artificial intelligence, only 39 described randomized controlled trials, making it difficult to quantify the clinical benefits of using AI-assisted tools for patient care.

By Nick Paul Taylor • Aug. 26, 2022

Smartphone-linked blood pressure monitors fail to beat traditional devices, study finds

Individuals have been able to check their blood pressure at home using devices that lack connectivity features for years, raising the question of whether the technology improves outcomes.

By Nick Paul Taylor • Aug. 16, 2022

Abbott blood test predicts death, unfavorable outcomes in traumatic brain injury patients, study finds

Abbott is pursuing FDA clearance for the breakthrough-designated TBI test to expand access to a diagnostic that predicted death and severe disability.

By Nick Paul Taylor • Aug. 12, 2022

Lack of clinical evidence 'major gap' in digital health: study

The researchers framed the low scores as evidence of “a major gap in health care technology,” adding that there is a “significant opportunity” for companies that differentiate themselves with a more rigorous approach.

By Nick Paul Taylor • June 22, 2022

Abbott, Medtronic make case for key diabetes products in ADA presentations

Researchers at Abbott Laboratories used the event to highlight data on the FreeStyle Libre 3 continuous glucose monitor, while Medtronic arrived at the sessions with real-world results on the MiniMed 780G insulin pump.

By Nick Paul Taylor • June 6, 2022

Verily advances smartwatch toward Parkinson's clinical trial use after validating technology

The researchers concluded the wearable device could reduce the sample size needed to show the effect of a therapeutic intervention.

By Nick Paul Taylor • May 25, 2022

Moving beyond paper workflows for medical device trials

Most clinical trial solutions aren't right-sized for medical device trials. So what do sponsors do?

May 23, 2022

Edwards posts 97% success rate with tricuspid device in 30-day test as it prepares for Abbott rival

Edwards' device posted a 97% implant success rate, while Abbott's had a 98% success rate. Both are part of a growing market for transcatheter valve repair devices. 

By Nick Paul Taylor • May 20, 2022

Study shows that Abbott's Amulet, Boston Scientific's Watchman devices are riskier for women

The analysis builds on previous studies showing that left atrial appendage occlusion devices are riskier for women. However, Abbott's recent study shows comparable outcomes for men and women at 18 months.

By Nick Paul Taylor • May 19, 2022

Medtronic links renal denervation to increased time below blood-pressure threshold

Results from two studies come after the medtech company had a setback in renal denervation in October. Medtronic is expected to report results from its pivotal trial this year.

By Nick Paul Taylor • May 18, 2022

Advocacy groups support patient engagement in MDUFA V, raise concerns about device safety

Patient groups are largely supportive of the new agreement, which the FDA will finalize and send to Congress. However, some have raised concerns that the deal is too focused on industry’s interests.

By Elise Reuter • April 20, 2022

Senators drill down on rising user fees, cybersecurity and clinical trial diversity in MDUFA hearing

While Tuesday's Senate hearing did not include FDA officials, lawmakers questioned industry groups as they consider the MDUFA V agreement that would increase the amount the agency can collect in fees from device makers.

By Elise Reuter • April 6, 2022

Nearly 80% of patients with infection following cardiac implant not treated appropriately: study

A Duke University study, which was supported by Philips, showed that roughly four out of five patients with an infection following a cardiac implant did not have devices extracted, which goes against clinical guidelines.

By Ricky Zipp • April 5, 2022

Medtronic self-expanding TAVR shows durability benefit over surgery at 5 years, analysis shows

Data from from multiple trials presented at ACC's Scientific Sessions showed the rate of structural valve deterioration at five years with surgery was 4.38% versus 2.57% in patients undergoing transcatheter aortic valve replacement.

By Greg Slabodkin • April 5, 2022

Medtronic posts positive 3-year data in renal denervation ahead of pivotal readout

Recent clinical trial results showed Medtronic's device reduced blood pressure out to three years, but analysts cautioned against using the results as a guide for the upcoming pivotal data.

By Nick Paul Taylor • April 5, 2022

iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients

Data presented at ACC's Scientific Sessions show that by using iRhythm's Zio to monitor patients after discharge, physicians reduced hospital stays and potentially improved identification of arrhythmia.

By Nick Paul Taylor • April 4, 2022

US replaces EU as priority market for medtech industry: survey

A survey of more than 100 executives at medical device companies found 89% of medtechs plan to prioritize U.S. regulatory approval going forward. One CEO said the EU's Medical Device Regulation "is killing innovation."

By Nick Paul Taylor • March 16, 2022

Guardant Health targets colorectal cancer screening in 2022

CEO Helmy Eltoukhy tells MedTech Dive the precision oncology company plans to launch a liquid biopsy in the first half of the year, rivaling Exact Sciences' Cologuard stool test.

By Greg Slabodkin • Feb. 8, 2022

Edwards-backed Corvia fails pivotal heart failure trial but clings to subgroup efficacy signal

Corvia Medical's atrial shunt therapy has failed to improve cardiovascular disease outcomes in heart failure patients, according to clinical trial results. 

By Nick Paul Taylor • Feb. 2, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests

A study found Exact's second-generation stool test has a lower false positive rate than the current product and is better at detecting precancerous lesions. But it is facing competing blood tests from Freenome and Guardant Health.

By Nick Paul Taylor • Jan. 20, 2022

User growth, product delays and a Super Bowl ad: Diabetes tech heads into 2022 after another eventful year

Diabetes tech companies are heading into 2022 with momentum as insulin pump and CGM use climbs and with key product launches on the horizon. Here are MedTech Dive's top sector stories in 2021.

Dec. 28, 2021

Neurostimulator to treat stroke fails to gain FDA advisory panel support

The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.

By Susan Kelly • Dec. 13, 2021