Clinical Trials: Page 3
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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 -
Sponsored by Medrio
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 -
Q&A
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Vaccine makers move quickly to confront omicron threat
Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.
By Ned Pagliarulo • Nov. 29, 2021 -
FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults
The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country.
By Ben Fidler • Nov. 19, 2021 -
Latest Abbott, Boston Scientific LAAC devices yield mixed results in first clinical comparison
No clear difference was evident in clinical outcomes at 45 days, but other endpoints did point toward potential pros and cons of the two left atrial appendage closure devices.
By Nick Paul Taylor • Nov. 8, 2021 -
Edwards, Medtronic bolster economic, clinical case for using TAVR over surgery
Medtronic released five-year data from the SURTAVI trial while Edwards presented a two-year study of the costs of TAVR and surgery, both of which were late-breaking clinical trials at the TCT annual scientific symposium.
By Nick Paul Taylor • Nov. 8, 2021 -
Siemens' Varian leads latest FDA breakthrough device designations
Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.
By Nick Paul Taylor • Nov. 1, 2021 -
Q&A
Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges
Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.
By Ricky Zipp • Oct. 20, 2021 -
Medtronic misses bid for early FDA OK in renal denervation, stock slides
The independent data safety monitoring board found the clinical trial needs to keep enrolling patients and gather results to show if the treatment works.
By Nick Paul Taylor • Oct. 18, 2021