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BioWorld - Monday, June 15, 2026
Home » Topics » Clinical, Medical technology

Clinical, Medical technology
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Illustration of head with circuit board brain
ASCO 2025

It’s time for more trust in AI, panel says

June 2, 2025
By Lee Landenberger
No Comments
Despite the advancement of AI and machine learning technologies and their incorporation into cancer treatment and drug development, a lack of trust and understanding of these new approaches is impeding care and treatment.
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LYR-210 device unfurling

Redemption for Lyra as second phase III rhinosinusitis trial hits goal

June 2, 2025
By Jennifer Boggs
No Comments
Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.
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Product image

FDA greenlights Distalmotion’s Dexter for gallbladder removal

May 29, 2025
By Shani Alexander
The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted in 2024 for use in inguinal hernia repair.
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Boston Scientific Acurate Prime Aortic Valve System

In TAVR setback, Boston Sci pulls plug on Acurate valves

May 28, 2025
By Holland Johnson
Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems
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Device in heart
EuroPCR 2025

Edwards' data shows benefits of early intervention in aortic stenosis

May 23, 2025
By Shani Alexander
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
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TRiCaresTopaz
EuroPCR 2025

Tricares Topaz valve significantly reduces tricuspid regurgitation

May 22, 2025
By Shani Alexander
Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz were at a TR grade ‘none’ (0+) or ‘mild’ (1+) following the procedure.
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3-30-Medtronic-Symplicity-Spyral.png
EuroPCR 2025

Medtronic reveals data on benefits of RDN system

May 21, 2025
By Shani Alexander
Medtronic plc revealed data at the EuroPCR conference which showed there was a significant, safe and sustained blood pressure reduction in patients treated with its Spyral renal denervation system who meet European recommended guidelines criteria over a three-year period.
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Elixir Medical DynamX
EuroPCR 2025

Dynamx bioadaptor superior to Resolute Onyx DES

May 21, 2025
By Shani Alexander
Three-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system continued to see lower adverse events rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent .
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MHRA logo

MHRA drafting guidance for RW clinical studies control arm

May 21, 2025
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.
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Shockwave IVL

EMPOWER CAD study confirms benefits of IVL-first strategy in women

May 20, 2025
By Shani Alexander
Shockwave Medical Inc., a unit of Johnson & Johnson Medtech, reported positive 30-day results from the EMPOWER CAD trial, which used its intravascular lithotripsy system in women with complex, calcified coronary artery disease. The results from the first prospective, real-world percutaneous coronary intervention study in female patients confirmed the benefit of coronary patients as seen in other retrospective analyses.
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