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BioWorld - Saturday, January 17, 2026
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Sooma device with laptop

Sooma receives IDE for neurostimulation therapy for depression

March 11, 2025
By Shani Alexander
Sooma Oy secured U.S. FDA investigational device exemption approval to initiate a pivotal study of its transcranial direct current stimulation medical device in people with major depressive disorder. The study will examine the efficacy of the non-invasive Sooma 2Gen device in improving MDD as an at-home treatment.
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Medtronic Prevail

SCAAR data Prevails for Medtronic paclitaxel-coated balloon

March 11, 2025
By Holland Johnson
Medtronic plc reported results from a registry highlighting the effectiveness of the Prevail paclitaxel-coated balloon. The findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) were presented by Sacharias von Koch of the department of cardiology and clinical sciences at Lund University, Skåne University Hospital in Sweden at the Cardiovascular Research Technologies 2025 meeting in Washington.
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Evolut device image

Medtronic sees SMART TAVR results in small aortic annulus patients

March 10, 2025
By Holland Johnson
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.
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Onward Arc IM system

Onward exploring spinal cord stimulation system to treat Parkinson’s

March 5, 2025
By Shani Alexander
Onward Medical NV’s spinal cord stimulation system Arc-IM is being investigated to explore its potential to help people with Parkinson's disease.
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Cancer tumor in breast illustration

Scientists develop scanner to see undetectable breast tumors​

Feb. 26, 2025
By Shani Alexander
Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods.
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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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