Clinical Trials: Page
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Courtesy of Abbott
Abbott starts study of PFA device in humans, targets 2024 US trial
RBC analysts predict Volt could launch in the U.S. as early as 2026.
By Nick Paul Taylor • Jan. 19, 2024 -
Sara Silbiger via Getty Images
FDA drafts guidance outlining real-world evidence for medical device submissions
By issuing the new guidance, the agency is meeting the requirements of a year-end spending bill.
By Elise Reuter • Dec. 19, 2023 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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Freenome starts 20,000-subject study of lung cancer blood test
The privately held company claims its test could offer an alternative to CT imaging, which exposes people to radiation.
By Nick Paul Taylor • Dec. 14, 2023 -
Photo illustration: Shaun Lucas/Industry Dive; CRISPR Therapeutics; Gregor Fischer/DPA/Newscom
Deep Dive‘No tolerance for failure’: An oral history of the first CRISPR medicine
A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.
By Ned Pagliarulo , Shaun Lucas • Dec. 13, 2023 -
Permission granted by Empatica
Empatica aims to develop seizure-forecasting algorithm based on wearable data
The company plans a study using its wrist-worn device to capture real-world data that could help understand and predict seizures for people with epilepsy.
By Nick Paul Taylor • Dec. 1, 2023 -
Christopher Furlong via Getty Images
AstraZeneca creates digital health unit, with big-name partnerships already in place
Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.
By Jacob Bell • Nov. 20, 2023 -
Courtesy of Abbott
Abbott study links aspirin-free regimen to better outcomes in heart pump patients
An accompanying editorial said the “data provide an opportunity to immediately improve the outcomes of patients implanted with contemporary LVADs.”
By Nick Paul Taylor • Nov. 15, 2023 -
Permission granted by Boston Scientific
Large registry study upholds safety findings for Boston Scientific’s Farapulse device
The results, presented at the American Heart Association Scientific Sessions, showed a low rate of adverse events for the pulsed-field ablation treatment.
By Elise Reuter • Nov. 14, 2023 -
Win McNamee/Getty Images via Getty Images
Biden initiative aims to accelerate women’s health research
AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.
By Susan Kelly • Nov. 14, 2023 -
Getty Images
Wegovy study details revive debate over GLP-1 impact on devices
The data confirmed a cardiovascular benefit for heart patients and showed the drug could help pre-diabetic patients control their blood sugar.
By Susan Kelly • Nov. 13, 2023 -
Courtesy of Johnson & Johnson
J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study
Scores on a quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device.
By Nick Paul Taylor • Nov. 6, 2023 -
Permission granted by Penumbra
Penumbra touts benefits of vacuum thrombectomy for PE in late-breaking data
An interim analysis of Penumbra’s Indigo aspiration system met its primary safety and efficacy criteria, according to data shared at the Vascular Interventional Advances Conference.
By Elise Reuter • Nov. 3, 2023 -
Courtesy of Edwards Lifesciences
Edwards posts early look at tricuspid device, stoking Abbott rivalry ahead of FDA panel
Nearly 94% of patients had their condition improve to mild or no tricuspid regurgitation six months after treatment, according to the study.
By Nick Paul Taylor • Oct. 27, 2023 -
Courtesy of Abbott
Abbott’s resorbable scaffold improves outcomes in below-the-knee artery disease, study finds
The device maker plans to submit the Esprit BTK data to the Food and Drug Administration for review.
By Nick Paul Taylor • Oct. 26, 2023 -
Permission granted by Boston Scientific
Boston Scientific study results support coronary drug-coated balloon in US
The results, shared at TCT 2023, found the company’s drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries.
By Elise Reuter • Oct. 25, 2023 -
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Edwards, Medtronic post low-risk TAVR data, allaying fears of market disruption
The late-breaking results, shared at TCT 2023, will have little impact on clinical practice or market share, J.P. Morgan and Stifel analysts predicted.
By Nick Paul Taylor • Oct. 25, 2023 -
Courtesy of https://www.edwards.com/devices/heart-valves/transcatheter-SAPIEN-3-Ultra
Physicians forecast Edwards’ 5-year data will have limited impact on low-risk TAVR market
Some doctors think TAVR may perform numerically worse but see little impact on the market unless there is a statistically significant result.
By Nick Paul Taylor • Oct. 20, 2023 -
Retrieved from Adobe Stock.
Duke researchers find app improves autism screening in NIH-funded study
Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.
By Nick Paul Taylor • Oct. 4, 2023 -
Getty Images
Harbinger Health raises $140M to study blood-based cancer screening test
The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.
By Nick Paul Taylor • Sept. 28, 2023 -
Getty Images
Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts
It is not yet clear how different approaches would benefit specific patients, creating uncertainty about which businesses will profit from the shift.
By Nick Paul Taylor • Sept. 26, 2023 -
Mario Tama via Getty Images
J&J starts trial of pulsed field ablation catheter with mapping feedback
Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data.
By Nick Paul Taylor • Sept. 19, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA releases draft guidance for studying weight loss devices
The documents arrive amid questions about whether new medicines will cut demand for weight loss procedures.
By Nick Paul Taylor • Sept. 19, 2023 -
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Beacon Biosignals receives FDA clearance for sleep tracking headband
The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.
By Nick Paul Taylor • Sept. 18, 2023 -
Getty Images
FDA finalizes combination product guidance 7 years after sharing draft
AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”
By Nick Paul Taylor • Sept. 13, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA proposes 3 guidances to improve 510(k) clearance process
The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.
By Nick Paul Taylor • Sept. 7, 2023
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