Clinical Trials: Page 2
-
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FDA shares draft guidance on clinical trial diversity action plans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 -
Courtesy of Edwards Lifesciences
Edwards pushes back on Medtronic’s head-to-head TAVR trial
Edwards Lifesciences and Wall Street analysts questioned the results of Medtronic’s women-focused study, claiming the data are inconsistent with real-world evidence.
By Susan Kelly • April 15, 2024 -
Courtesy of Exact Sciences
Exact Sciences’ cancer blood test achieves 51% sensitivity in prospective trial
Sensitivity for the multi-cancer early detection test rose to almost 64% in the six cancers with the shortest five-year survival rate.
By Nick Paul Taylor • April 9, 2024 -
Permission granted by Medtronic
Medtronic beats Edwards on valve dysfunction in TAVR study
In a head-to-head clinical trial, Medtronic linked its device to a lower rate of valve dysfunction than Edwards’ rival product in a subpopulation of patients.
By Nick Paul Taylor • April 8, 2024 -
Dmitry Belyaev via Getty Images
Freenome’s colorectal cancer blood test data underwhelm analysts
Cowen analysts said Freenome’s results are good news for competitors Exact Sciences and Guardant Health.
By Nick Paul Taylor • April 5, 2024 -
Courtesy of Exact Sciences
Exact Sciences, Mayo Clinic share early data on esophageal cancer test
Designed as an alternative to endoscopy, the cancer screening test uses a sponge collection device that's paired with an algorithm.
By Elise Reuter • March 29, 2024 -
Courtesy of Business Wire
Guardant posts data for colon cancer blood test amid push from rivals
The NEJM paper presents data from a study of more than 10,000 people Guardant ran to support authorization of its Shield DNA test.
By Nick Paul Taylor • March 18, 2024 -
Permission granted by Becton Dickinson
BD starts trial of vascular covered stent in peripheral arterial disease
Peripheral vascular disease is one of six key platforms BD is targeting for growth.
By Nick Paul Taylor • March 5, 2024 -
Mario Tama via Getty Images
J&J unveils Varipulse data at AF Symposium
The results compare favorably to data from Boston Scientific and Medtronic, although analysts noted that J&J enrolled younger patients.
By Nick Paul Taylor • Feb. 6, 2024 -
Courtesy of Medtronic
Medtronic’s closed-loop neuromodulation device cuts overstimulation in trial
Most participants reported a significant reduction in overstimulation compared to open-loop spinal cord stimulation.
By Nick Paul Taylor • Jan. 22, 2024 -
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 -
Mohammed Haneefa Nizamudeen via Getty Images
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
Previous
