Clinical Trials
-
Courtesy of Boston Scientific
Boston Scientific’s Watchman could be new option for patients post ablation: study
The trial compared the stroke prevention device for left atrial appendage closure to blood thinners in people who underwent cardiac ablation for AFib.
By Susan Kelly • Nov. 18, 2024 -
Photo by MART PRODUCTION from Pexels
Livanova hits sleep apnea trial goals, plans FDA filing
Leerink analysts said the results were largely in line with outcomes in a trial of Inspire Medical’s rival device but cautioned that Livanova may have a hard time breaking into the sleep apnea market.
By Nick Paul Taylor • Nov. 13, 2024 -
Courtesy of Johnson & Johnson
J&J’s Ottava surgical robot to begin clinical trial after FDA nod
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging Intuitive Surgical’s da Vinci system.
By Susan Kelly • Nov. 12, 2024 -
Permission granted by Boston Scientific
Boston Scientific resumes PFA trial in new patient group after pausing enrollment
Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.
By Susan Kelly • Nov. 12, 2024 -
Courtesy of Edwards Lifesciences
Edwards, Medtronic and Inari share trial data at TCT conference
The three medtech firms unveiled new data this week during TCT 2024 in Washington, D.C. Here’s what the results mean for the companies and their device markets.
By Nick Paul Taylor • Oct. 31, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study
Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.
By Susan Kelly • Oct. 31, 2024 -
Edwards data show benefit of early TAVR over ‘watchful waiting’
Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”
By Susan Kelly • Oct. 29, 2024 -
Courtesy of Abiomed
J&J to seek FDA approval after small-bore Impella heart pump hits trial goal
The company has predicted the narrower Impella ECP will be easier to insert and implant, as well as enable the use of small bore access and closure techniques.
By Nick Paul Taylor • Oct. 29, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceThat’s a wrap: 5 takeaways from The Medtech Conference
The conference — Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.
By Elise Reuter • Oct. 22, 2024 -
Courtesy of Abbott
Abbott enrolls pivotal PFA study 4 months ahead of schedule
The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.
By Nick Paul Taylor • Oct. 11, 2024 -
Courtesy of Procept Biorobotics
Procept secures FDA approval to study surgical robot in prostate cancer
The trial will compare the therapy to radical prostatectomy and could unlock a market that analysts value at $500 million.
By Nick Paul Taylor • Oct. 9, 2024 -
halbergman via Getty Images
Top medtech conferences in 2025
The lineup includes industrywide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.
By Ricky Zipp • Oct. 1, 2024 -
Courtesy of Synchron
Synchron’s brain-computer interface tech meets safety goal
The six-patient trial also indicated the device worked, according to Synchron, with the conversion of brain signals to motor outputs allowing people to perform digital tasks.
By Nick Paul Taylor • Oct. 1, 2024 -
Courtesy of Business Wire/Exact Sciences
Exact Sciences says data support its colon cancer blood test
Exact’s test could compete with Guardant Health’s Shield blood test, which received approval from the Food and Drug Administration in July.
By Susan Kelly • Sept. 16, 2024 -
Sarah Silbiger via Getty Images
FDA seeks feedback on health equity for medical devices
The agency plans to develop a framework for when devices should be evaluated in diverse populations to support marketing authorization.
By Nick Paul Taylor • Aug. 6, 2024 -
Sarah Silbiger/Getty Images via Getty Images
FDA finalizes guidance on studying opioid use disorder treatments
The Center for Devices and Radiological Health is aiming to help companies manage challenges such as inaccurate participant reports of drug use.
By Nick Paul Taylor • July 12, 2024 -
Sarah Silbiger via Getty Images
FDA shares draft guidance on clinical trial diversity action plans
The agency said which trials need diversity action plans and presented the timeline for implementing the requirement.
By Nick Paul Taylor • June 28, 2024 -
Courtesy of Insulet Corp.
Insulet seeks label expansion of Omnipod 5 for Type 2 diabetes
At the American Diabetes Association meeting, Insulet shared study results showing improvements in blood glucose and quality of life.
By Elise Reuter • June 24, 2024 -
SDI Productions via Getty Images
Women underrepresented in trials of high-risk medical implants: study
A median of 33% of study subjects were women, and the figure was significantly lower in cardiovascular trials.
By Nick Paul Taylor • June 12, 2024 -
Sapien valve performs equally well for small and large aortic annuli, Edwards finds
The analysis adds to a debate about the effectiveness of Edwards versus Medtronic TAVR devices in patients with small aortic annuli, a fibrous ring around the heart’s valve.
By Nick Paul Taylor • June 6, 2024 -
Dr_Microbe via Getty Images
Saliva test identifies men at high risk of prostate cancer
Data presented at the American Society of Clinical Oncology meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.
By Nick Paul Taylor • June 5, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s cardiac rhythm system hits pivotal trial goals
Boston Scientific, which presented the results at the Heart Rhythm Society meeting, expects to receive FDA approval for the system in 2025.
By Nick Paul Taylor • May 21, 2024 -
Courtesy of Johnson & Johnson
J&J posts latest Varipulse data while awaiting FDA review
Johnson & Johnson is chasing Medtronic and Boston Scientific in the U.S. for a share of the rapidly growing pulsed field ablation market.
By Nick Paul Taylor • May 20, 2024 -
Justin Sullivan via Getty Images
FDA qualifies Apple Watch AFib feature for use in clinical trials
Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.
By Nick Paul Taylor • May 6, 2024 -
Scott Olson via Getty Images
Lilly obesity drug shows benefit in sleep disorder study, pointing to new use
Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.
By Jonathan Gardner • April 17, 2024
