Clinical Trials: Page 2
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Courtesy of Boston Scientific
Boston Scientific’s pivotal pulsed field ablation trial expected to succeed: analysts
Positive results could position Boston Scientific to win U.S. approval for Farapulse in the second half of next year.
By Nick Paul Taylor • Aug. 14, 2023 -
Douglas Cliff via Getty Images
Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts
Issues such as “nontrivial side effects, cost concerns and patient persistence” will mean physicians continue to use medical devices, analysts say.
By Nick Paul Taylor • Aug. 9, 2023 -
libre de droit via Getty Images
Penumbra says stroke device delayed at least 12 months due to FDA request
The setback stalls “a meaningful new product catalyst,” but the growth of Penumbra’s other devices could cushion the impact, analysts said.
By Nick Paul Taylor • Aug. 4, 2023 -
Thomas Andreas via Getty Images
AI reduces radiologist workload in mammography clinical trial but expert urges caution
The trial linked the AI-supported screen-reading procedure, ScreenPoint Medical’s Transpara, to a 44% reduction in radiologist workload.
By Nick Paul Taylor • Aug. 2, 2023 -
Sara Silbiger via Getty Images
FDA shares draft guidance on studying medtech treatments for opioid use disorder
The FDA aims to address challenges including inaccurate self-reported drug use, missing data and the need to show the durability of the treatment.
By Nick Paul Taylor • July 28, 2023 -
Ijubaphoto via Getty Images
Hearing aids fail to improve cognition in randomized trial, but subgroup analysis offers hope
While there were no positive effects observed in healthy older adults, a smaller analysis pointed to a difference in those at higher risk of cognitive decline.
By Nick Paul Taylor • July 18, 2023 -
Retrieved from Istock.
FDA seeks feedback on technologies that can enable healthcare at home
The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.
By Nick Paul Taylor • June 29, 2023 -
Permission granted by Medtronic
Medtronic links 780G insulin pump to benefits in kids as it works to grow sales
A clinical trial found adolescent users of the pump can achieve improved blood glucose control without precisely counting carbohydrates.
By Nick Paul Taylor • June 26, 2023 -
Courtesy of Bigfoot Medical
Bigfoot links smart insulin pen cap to improved glycemic control in real-world study
Using the system can bring “rapid and durable improvement” in glycemic control for older adults with Type 2 diabetes who use multiple daily injections, researchers found.
By Nick Paul Taylor • June 22, 2023 -
Courtesy of Exact Sciences/Business Wire
Exact Sciences’ next-gen colorectal cancer test hits primary goals in pivotal study
The analysis suggests the new stool-based test provides more true positives and fewer false positives than its predecessor.
By Nick Paul Taylor • June 21, 2023 -
Stock via Getty Images
Precision Neuroscience’s brain implant maps electrical activity in a first-in-human trial
Created by a founder of Elon Musk’s Neuralink, Precision has developed a device with some 1,000 electrodes in a one square centimeter flexible film. The trial could open the way to a computer-brain interface.
By Nick Paul Taylor • June 8, 2023 -
Courtesy of Cue Health Press Kit
Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade
The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.
By Peter Green • June 7, 2023 -
Permission granted by Abbott
Abbott’s remote heart failure monitoring system reduces hospitalizations in clinical trial
The study is the third randomized, controlled trial globally to link CardioMEMS to a significant health benefit.
By Nick Paul Taylor • May 26, 2023 -
Justin Sullivan via Getty Images
PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias
In a head-to-head comparison with Apple’s pre-installed software for interpreting ECG data, Pulse AI’s algorithm was better at detecting atrial arrhythmias.
By Nick Paul Taylor • May 23, 2023 -
Stock via Getty Images
Abbott, Boston Scientific, Medtronic share data on heart rhythm devices at conference
A series of recent innovations in pacemaker technology has opened up new markets and set the stage for increased competition.
By Nick Paul Taylor • May 22, 2023 -
Adam Berry via Getty Images
Chinese medtechs post data on renal denervation devices to rival Medtronic, ReCor
The findings validate the technique used by Medtronic and ReCor, while suggesting the U.S. companies will face competition if they target the Chinese market.
By Nick Paul Taylor • May 19, 2023 -
Courtesy of Abbott
Abbott shares data showing benefit of TriClip device amid FDA review
Patients experienced a reduction in tricuspid regurgitation and had improved heart function, according to late-breaking data presented at EuroPCR.
By Elise Reuter • May 18, 2023 -
Photo by MART Productions from Pexels
Clinical trials showcase potential roles for ultrasound in treating cancer, inflammatory disease
The use of ultrasound as a therapeutic device could lead to new treatment options. In one study, patients with brain tumors received an ultrasound implant that allowed a drug to enter the brain.
By Nick Paul Taylor • May 18, 2023 -
Courtesy of Verily
Diabetes app developers must generate more data on clinical effectiveness, study says
The researchers saw a need for more data on the wider clinical effectiveness of apps in the management of Type 1 diabetes and prediabetes.
By Nick Paul Taylor • May 16, 2023 -
Courtesy of GuardantHealth
Guardant blood test detects 83% of colorectal cancer cases, but fewer in early stage
Analysts said the test is likely to meet the bar for FDA approval, but its flaws in detecting early-stage cancer weaken its chances against Exact Sciences’ stool-based test, Cologuard.
By Elise Reuter • May 10, 2023 -
Kevin Dietsch via Getty Images
FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech
The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.
By Nick Paul Taylor • May 9, 2023 -
iStock via Getty Images
Algorithm may help avoid 40% of kidney transplant rejection misdiagnoses: study
The decision-support system “could have important clinical implications for the management and treatment of transplant recipients,” researchers found.
By Nick Paul Taylor • May 5, 2023 -
Sarah Silbiger via Getty Images
FDA posts draft guidance on studying medical devices in decentralized clinical trials
Analysts at Cowen said the draft could reassure sponsors they can run decentralized trials without complicating approvals.
By Nick Paul Taylor • May 4, 2023 -
Permission granted by Johnson & Johnson
J&J study data show dramatic benefit to multiple myeloma cell therapy
A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.
By Ned Pagliarulo • April 19, 2023 -
Stock via Getty Images
AFib study shows no effect on outcomes from 1-year delay of catheter ablation
Early treatment could be a boon for medtech companies such as Boston Scientific and Medtronic but is potentially challenging for healthcare systems. The new study suggests waits of up to a year will not harm patients.
By Nick Paul Taylor • April 19, 2023
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