Fluoroscopy

Kardium announces positive 1-year outcomes for PULSE-EU trial with the Globe® System, showing promise for improving the treatment of atrial fibrillation

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Mercoledì, Maggio 29, 2024

Kardium Inc. , a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial.

Key Points: 
  • Kardium Inc. , a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial.
  • “The Globe System achieved outstanding freedom from atrial arrhythmia in both Paroxysmal and Persistent patients, with no device- or procedure-related major adverse events.
  • “These excellent results of the PULSE-EU Trial reflect Kardium’s ongoing dedication to develop the best treatment for Atrial Fibrillation”, said Kevin Chaplin, CEO of Kardium.
  • Kardium has built an outstanding team, who have worked with top medical advisors to develop the Globe System.

Favorable Clinical Data for Applaud Medical’s Novel Technology for Treating Urinary Stones Presented During the 2024 AUA Annual Meeting

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Lunedì, Maggio 6, 2024

Applaud Medical, an emerging leader in the treatment of urinary stones, today announced positive results from a prospective, multicenter study of the company’s BRIO Enhanced Lithotripsy System (ELS) for the treatment of obstructive ureteral stones.

Key Points: 
  • Applaud Medical, an emerging leader in the treatment of urinary stones, today announced positive results from a prospective, multicenter study of the company’s BRIO Enhanced Lithotripsy System (ELS) for the treatment of obstructive ureteral stones.
  • The results were presented as a podium presentation during the American Urological Association's (AUA) 2024 Annual Meeting held in San Antonio, Texas.
  • The study combined Applaud Medical’s proprietary acoustically enhanced microbubbles with a low-pressure ultrasound system to treat ureteral stones.
  • Our solution aims to eliminate ureteral stones quickly, affordably, and without general anesthesia or fluoroscopy, bringing it to a physician’s office and other non-hospital settings.”

Thubrikar Aortic Valve Announces Clinical Success of the New Precision 2™ Delivery Catheter

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Lunedì, Maggio 6, 2024

Thubrikar Aortic Valve, Inc. today announced successful results in the first two patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV™) using the new Precision 2™ Delivery Catheter.

Key Points: 
  • Thubrikar Aortic Valve, Inc. today announced successful results in the first two patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV™) using the new Precision 2™ Delivery Catheter.
  • “The first two implants with the 2nd-generation delivery catheter could not be easier or more effective.
  • Due to the innovative catheter design and the Optimum TAV’s short frame, the valve reorients as it is deployed resulting in automatic axial alignment with the native valve.
  • Dr. Mano Thubrikar, the Company’s Founder and President, stated, “The Optimum TAVI System offers patients a more durable transcatheter valve and physicians a more user-friendly delivery catheter.

SwiftDuct Presents Positive Clinical Study Results of SwiftGlide For ERCP Procedures at ESGE Days 2024

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Giovedì, Maggio 2, 2024

SAKHNIN, Israel, May 2, 2024 /PRNewswire/ -- In a poster presentation at the 2024 annual meeting of the European Society of Gastrointestinal Endoscopy, ESGE Days 2024, SwiftDuct announced the positive findings of the first clinical trial of SwiftGlide™, the company's electrochemical navigation system for ERCP procedures.

Key Points: 
  • SwiftDuct's first clinical study, which was conducted at Galilee Medical Center, demonstrates that the company's electrochemical navigation method has the potential to improve ERCP procedures and outcomes, marking an important milestone towards Fluoroscopy-Free ERCP cannulation.
  • ERCP is a widely used procedure to diagnose and treat issues in the bile or pancreatic ducts.
  • SAKHNIN, Israel, May 2, 2024 /PRNewswire/ -- In a poster presentation at the 2024 annual meeting of the European Society of Gastrointestinal Endoscopy, ESGE Days 2024 , SwiftDuct announced the positive findings of the first clinical trial of SwiftGlide™, the company's electrochemical navigation system for ERCP procedures.
  • The study showed that SwiftGlide™ was successful in differentiating between bile and pancreatic/mixed juices as the basis to providing selective and safe biliary cannulation during ERCP procedures.

New Field Data Shows High Diagnostic Yield for Lung Biopsy Diagnosis Using the Galaxy System™

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Giovedì, Aprile 18, 2024

Key findings include:

Key Points: 
  • Key findings include:
    The papers reported diagnostic yield with a range of 92-96% observed by Dr. Hogarth and 96% by Dr. Mahajan.
  • The average lesion size ranged from 14mm to 16mm, with more than one-third of them less than or equal to 10mm in size.
  • The University of Chicago’s Dr. Kyle Hogarth was the first user of the Galaxy System in the United States.
  • The whitepapers, based on data obtained from Dr. Hogarth and Dr. Mahajan, are now available and can be found here .

Merit Medical Launches the Micro ACE™ Advanced Micro-Access System

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Martedì, Marzo 19, 2024

SOUTH JORDAN, Utah, March 19, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced commercial release of its US Food and Drug Administration (FDA)-cleared Micro ACE Advanced Micro-Access System.

Key Points: 
  • SOUTH JORDAN, Utah, March 19, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced commercial release of its US Food and Drug Administration (FDA)-cleared Micro ACE Advanced Micro-Access System.
  • Merit also intends to file Micro ACE for CE mark designation.
  • The Micro ACE system is the latest innovation in the Merit Vascular portfolio.
  • Combining a balance of stiffness and resiliency, Micro ACE is designed to achieve micro-access in a wide range of vascular anatomies.

Vektor Medical Announces Publication of vMap Study Results in Journal of Cardiovascular Electrophysiology

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Martedì, Aprile 2, 2024

Vektor Medical, a pioneer in non-invasive, AI-based arrhythmia analysis technology, today announced the publication of data in the Journal of Cardiovascular Electrophysiology (JACE) demonstrating vMap’s ability to reduce the time from mapping to treatment, procedure duration, and fluoroscopy when treating cardiac arrhythmia patients with ablation therapy.

Key Points: 
  • Vektor Medical, a pioneer in non-invasive, AI-based arrhythmia analysis technology, today announced the publication of data in the Journal of Cardiovascular Electrophysiology (JACE) demonstrating vMap’s ability to reduce the time from mapping to treatment, procedure duration, and fluoroscopy when treating cardiac arrhythmia patients with ablation therapy.
  • The study , “Impact Of Artificial Intelligence Arrhythmia Mapping on Time to First Ablation, Procedure Duration, and Fluoroscopy Use,” is a retrospective, case-controlled study of 28 patients with common arrhythmia types.
  • “By employing AI ECG arrhythmia mapping using 12-lead ECG data, the study shows increased procedural efficiency and improved patient safety by limiting exposure to fluoroscopy.
  • EPs can rely on vMap to reduce procedure times with increased confidence in positive outcomes.

Noah Medical Named a “Fierce 15” Company of 2023 by Fierce MedTech

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Mercoledì, Marzo 6, 2024

SAN CARLOS, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Medical robotics innovator Noah Medical announced today that Fierce MedTech has named it one of 2023’s “Fierce 15” medical technology companies.

Key Points: 
  • SAN CARLOS, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Medical robotics innovator Noah Medical announced today that Fierce MedTech has named it one of 2023’s “Fierce 15” medical technology companies.
  • “Winning the Fierce 15 award is a shared triumph for both our exceptional team at Noah and the customers who’ve played an instrumental role in making Galaxy a leader in minimally invasive early lung cancer diagnosis,” said Noah Medical CEO Jian Zhang.
  • The Galaxy System was also recently recognized as a Medtech Breakthrough winner and named a finalist in the 2023 Fierce Innovation Awards: Life Sciences Edition.
  • “These companies exemplify the ability of the MedTech industry to turn cutting-edge ideas into meaningful outcomes and make them accessible on a large scale.”
    To learn more about Noah Medical and the Galaxy System, please visit noahmed.com .

AOFAS Honors Two Female Orthopaedic Leaders

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Martedì, Febbraio 27, 2024

“I am proud that AOFAS is making an effort to recognize women in foot and ankle orthopaedic surgery.”

Key Points: 
  • “I am proud that AOFAS is making an effort to recognize women in foot and ankle orthopaedic surgery.”
    Over the past 15 years, Dr. Chou has conducted several research studies to examine breast cancer prevalence among female orthopaedic surgeons.
  • Dr. Chou’s research results confirmed higher breast cancer prevalence among female orthopaedic surgeons than the general population, and in a later study, she discovered higher prevalence among female orthopaedic surgeons compared to women in other surgical specialties.
  • Currently, she is leading a study to evaluate cancer risk associated with radiation exposure in male and female orthopaedic surgeons.
  • I applaud AOFAS for taking that initiative with these awards.”
    Funding for the AOFAS Women’s Leadership Initiative is provided by the Orthopaedic Foot & Ankle Foundation, supported by a grant from Treace Medical Concepts, Inc.

Body Vision Medical Announces Successful Validation of LungVision™ System with Fujifilm's Range of Surgical C-arms

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Martedì, Marzo 5, 2024

CAMPBELL, Calif., March 5, 2024 /PRNewswire/ -- Body Vision Medical, a leader in AI-driven, intraoperative imaging, announced today the successful validation of Body Vision's LungVision™ system with FUJIFILM Healthcare Americas Corporation's Persona line of C-arms and FDR Cross two-in-one fluoroscopy C-arm and portable digital radiography solution.

Key Points: 
  • CAMPBELL, Calif., March 5, 2024 /PRNewswire/ -- Body Vision Medical, a leader in AI-driven, intraoperative imaging, announced today the successful validation of Body Vision's LungVision™ system with FUJIFILM Healthcare Americas Corporation's Persona line of C-arms and FDR Cross two-in-one fluoroscopy C-arm and portable digital radiography solution.
  • Body Vision Medical's LungVision™ system uses artificial intelligence (AI) to transform X-ray images from any C-arm into real-time, intraoperative CT scans.
  • "This validation further demonstrates the power of an AI-driven imaging platform like LungVision™ that enables physicians to agnostically leverage our image-guided navigation and real-time imaging with the bronchoscopy platform and C-arm of their choice," said David Webster, CEO of Body Vision Medical.
  • "We're elated to see the successful validation of our C-arm platforms with Body Vision's leading LungVision™ system to synergistically provide the visualization needed by bronchoscopists during navigation bronchoscopy".