Clinical Trials: Page 4
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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 -
Courtesy of Walgreens
OTC hearing aid matches performance of audiologist-fitted device in small trial
People who used an over-the-counter hearing aid for six weeks saw similar results to people who used an audiologist-fitted device, suggesting less costly, self-fitted hearing aids could be an option.
By Nick Paul Taylor • April 13, 2023 -
Permission granted by Abbott
Implantable heart failure sensors cut death risk in study: Abbott
Philip Adamson, chief medical officer for Abbott’s heart failure business, called the finding “profound.”
By Susan Kelly • March 27, 2023 -
Courtesy of Tandem Diabetes
Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids
If Tandem can prove to regulators that the system can help manage young children’s diabetes, it could compete with Medtronic and Insulet, which have devices that are indicated for use in kids as young as two years.
By Nick Paul Taylor • March 16, 2023 -
Courtesy of Medtronic
Medtronic’s pulsed field ablation device meets safety, efficacy metrics in trial
Medtronic’s device didn’t outperform competing systems being developed by J&J and Boston Scientific, but the results should be enough to secure FDA approval, one analyst wrote.
By Elise Reuter • March 7, 2023 -
Permission granted by Medtronic
Medtronic TAVR data in healthier patients fuels battle with Edwards for heart valve market share
The results show that low-risk aortic stenosis patients have better outcomes after three years when catheters are used to insert their replacement heart valves, rather than traditional open-heart surgery.
By Nick Paul Taylor • March 7, 2023 -
Courtesy of Abbott
Abbott’s TriClip improves tricuspid regurgitation in pivotal trial ahead of showdown with Edwards
The transcatheter repair clip beat the established medical therapy on the primary composite endpoint, setting up a battle with rival Edwards for a $5 billion market.
By Nick Paul Taylor • March 6, 2023 -
Paula Bronstein via Getty Images
Phone app tracks cough frequency in tuberculosis trial, opening up monitoring opportunity
If validated in further studies, the work could further expand the use of smartphones as diagnostic tools, particularly in areas where there are few medical professionals, and could help stop overtreatment of TB.
By Nick Paul Taylor • March 6, 2023 -
Win McNamee / staff via Getty Images
Elon Musk’s bid to study brain implant in humans rejected by FDA on safety grounds: report
The FDA reportedly raised concerns about the device’s lithium battery, the potential for its wires to migrate across the brain, and how it would be removed.
By Nick Paul Taylor • March 3, 2023 -
Courtesy of Recor
ReCor follows Medtronic in making case for renal denervation as FDA mulls approval decision
An analysis of three clinical trials linked the intervention to consistent reductions in blood pressure.
By Nick Paul Taylor • March 1, 2023 -
Courtesy of Medtronic
Medtronic links MiniMed 780G automated insulin delivery to sustained glucose control benefits
The data indicates patients should receive automated insulin delivery earlier, rather than starting treatment with multiple daily injections, Medtronic said.
By Nick Paul Taylor • Feb. 27, 2023 -
libre de droit via Getty Images
Spinal cord stimulation shows ability to improve motor function in stroke patients in small trial
The spinal implant improved strength, grip force and movement, enabling participants to recover the use of limbs incapacitated by stroke.
By Nick Paul Taylor • Feb. 21, 2023
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