Clinical Trials
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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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
J&J, Medtronic, Boston Scientific gird for battle over US cardiac ablation market with new trials
Medtech firms are sharing clinical trial results on pulse ablation devices, which they claim are safer and more effective at halting arrhythmias than current methods.
By Elise Reuter • Feb. 8, 2023 -
CT scans offer new path to diagnose treatable cause of high blood pressure, study shows
While the approach could increase demand for CT imaging, the supply of radioactive tracers is potentially a barrier to adoption of the technique.
By Nick Paul Taylor • Jan. 19, 2023 -
AI predicts lung cancer risk six years into the future using single CT scan: study
A research team has made the deep learning model publicly available and says it has no intention to commercialize it.
By Nick Paul Taylor • Jan. 17, 2023 -
Labcorp hires ex-Quintiles CEO to lead clinical development unit ahead of upcoming spinoff
Thomas Pike, who oversaw the transformational merger of Quintiles and IMS Health, will be in charge of a CRO for the first time since 2016.
By Nick Paul Taylor • Jan. 6, 2023 -
AstraZeneca extends C2i pact to validate minimal residual disease solid tumor blood test
The technology could improve cancer treatment and support clinical trial recruitment and monitoring.
By Nick Paul Taylor • Jan. 6, 2023 -
Novocure shares jump on positive lung cancer data
A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.
By Jonathan Gardner • Jan. 5, 2023 -
Q&A
Freenome CEO Mike Nolan talks colorectal cancer test, clinical trials
The San Francisco-based company recently enrolled a clinical trial for its blood-based cancer test but faces competition in the market for minimally invasive cancer tests.
By Elise Reuter • Dec. 22, 2022 -
Medtronic starts US robotic surgery trial in push to challenge Intuitive
Medtronic delayed the Hugo program to make changes in light of surgeon feedback, but now plans to evaluate the use of the surgical robot in urologic procedures, facing off against competitor Intuitive.
By Nick Paul Taylor • Dec. 20, 2022 -
MDR costs are driving manufacturers to pull products from European market: report
The report adds to evidence that makers of products used for pediatric patients and rare diseases have been particularly hard hit.
By Nick Paul Taylor • Dec. 20, 2022 -
Pivotal data on Guardant’s colorectal cancer blood test raise doubts about commercial prospects
Guardant’s share price fell 27% after the release of the news, which raised questions about whether the test can drive sales growth.
By Nick Paul Taylor • Dec. 19, 2022 -
Gates, Bezos invest in Synchron’s brain computer interface
A $75 million investment will accelerate the development of a drill-free implant to help patients with upper-limb paralysis.
By Peter Green • Dec. 16, 2022 -
Investors hand Vaxxas $23M to support trial of needle-free COVID-19 vaccine
With support from the Gates Foundation, the needle-free technology could get more people vaccinated and avoid cold-chain issues.
By Nick Paul Taylor • Dec. 12, 2022 -
The 10 biggest medtech stories of 2022
MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.
By MedTech Dive staff • Dec. 3, 2022 -
UroMems starts clinical trial of smart, automated implant to treat incontinence
The device is designed to improve on products such as Boston Scientific’s AMS 800 by eliminating the need for manual adjustments.
By Nick Paul Taylor • Nov. 30, 2022 -
Apple earbuds show promise as hearing aids in clinical trial
The earbuds performed comparably to hearing aids in terms of speech perception in quiet environments.
By Nick Paul Taylor • Nov. 22, 2022 -
Medtronic’s renal denervation treatment ‘still a viable therapy’ despite study miss, doctors say
While the study missed its primary endpoint, the surgery likely will be an option for patients with drug-resistant hypertension.
By Elise Reuter • Nov. 17, 2022