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BioWorld - Friday, May 8, 2026
Home » Topics » Medical technology, Clinical

Medical technology, Clinical
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U.S. FDA headquarters

Raft of FDA job cuts may slow med-tech approvals

Feb. 21, 2025
By Holland Johnson
In response to the news of reported layoffs at the U.S. FDA over the weekend, Advanced Medical Association president and CEO Scott Whitaker said in press release that these “significant job cuts could have a very negative impact on patient care in this country.”
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BN Prospera SCS Device

Spinal cord stimulation system shows significant pain relief

Feb. 12, 2025
By Tamra Sami
Biotronik Neuro’s Prospera spinal cord stimulation system achieved more than 50% pain reduction for 86% of patients with back pain and 89% of patients with leg pain over two years, according to new study results.
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DBS for stroke

Newronika gets IDE from the FDA for adaptive DBS trial

Feb. 11, 2025
By Shani Alexander
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
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heartflow-diagnostic-8may24.jpg

Heartflow CT scan predicts cardiac events 7 years out

Feb. 10, 2025
By Annette Boyle
A 1,000-person study using Heartflow Inc. technology demonstrated that findings of coronary plaque on heart CT scans could indicate which patients were at risk of cardiovascular events up to seven years in the future – potentially providing a road map toward screening for heart disease, the leading cause of death for both men and women in the U.S. and worldwide.
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Pathology image of neuroendocrine tumor

ITM marks a milestone in radiotherapeutic tumor therapy

Jan. 28, 2025
By Lee Landenberger
With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors, met its primary endpoint of prolonging progression-free survival when compared to the mTOR inhibitor everolimus, a targeted molecular therapy and a standard of care.
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3D bioprinter printing cells onto an petri dish.

Bioprinting technique mimics heart tissue development

Jan. 28, 2025
By Shani Alexander
A new bioprinting platform to create tissues that can change shape as a result of forces generated by the cells, similar to what happens naturally during organ development, was developed by researchers from the University of Galway, Ireland.
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Accunea monitoring device

Accunea’s Renosure device could transform kidney transplantation

Jan. 24, 2025
By Shani Alexander
Accunea Ltd. is looking to reduce the number of kidneys that are discarded with its bioanalysis technology Renosure, which can detect critical changes in organ function in real-time, both before and after transplantation. The company is looking to raise £1.6 million (US$2 million) to develop the device which could transform the lives of people requiring a kidney transplant.
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Illustration of bionic arm

BCI enables sense of touch in bionic arm

Jan. 23, 2025
By Shani Alexander
In a boon for companies developing brain-computer interface (BCI) technologies, researchers have used a BCI and artificial intelligence to restore touch sensations in a bionic arm.
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FARAPULSE pulsed field ablation system

Boston Sci reports good data for Farapulse, Watchman afib systems

Jan. 17, 2025
By Holland Johnson
Boston Scientific Corp. reported positive data for two key atrial fibrillation therapies at AF Symposium 2025 on January 17. In late-breaking data presentations, the ADVANTAGE AF trial for the Farapulse PFA system met its primary endpoints, showing a 2.3% safety event rate and 63.5% effectiveness rate in treating persistent atrial fibrillation (AF) patients, with an 85.3% symptomatic AF recurrence-free rate. Additionally, a sub-analysis of the OPTION trial demonstrated that the Watchman FLX device significantly reduced bleeding outcomes compared to oral anticoagulants.
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Purple-tinted test tubes and dropper
JPM Healthcare Conference

Natera reports on robust product pipeline at JPM

Jan. 15, 2025
By Holland Johnson
Natera Inc., a developer of cell-free DNA testing, provided an update on its product portfolio at the J.P. Morgan Healthcare Conference on Jan. 15. The company disclosed a new version of the Signatera assay that leverages the genome. Natera said the test, now available for research and clinical use, enables bespoke assay design from a whole genome sequence of a patient’s tumor.
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