coronary arterial disease News
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CathWorks FFRangio System Receives Regulatory Approval in Japan
CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW). The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images into objective and comprehensive physiology information, ...
By CathWorks
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CathWorks FFRangio System Receives National Reimbursement Approval in Japan
CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application to provide reimbursement for the CathWorks FFRangio™ System, making it more broadly available for coronary artery disease decision-making in Japan. The CathWorks FFRangio™ System has already received regulatory approval from the Japanese Pharmaceuticals and Medical Devices ...
By CathWorks
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Mike Feher Appointed as CFO of CathWorks
CathWorks, a global leader of digital health innovation focused on helping patients with cardiovascular disease, announced today that Mike Feher was appointed Chief Financial Officer, effective immediately. An energetic and results-driven executive, Mr. Feher brings comprehensive strategic and operational finance experience to his role, including expertise in financial planning and analysis, ...
By CathWorks
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CathWorks FFRangio System Case Review - Highlight from Dr. Rahul Sharma’s CVIT Presentation
The CathWorks FFRangio System is revolutionizing treatment decisions for coronary artery disease with quick, non-invasive, wire-free 3D FFR guidance. In this excerpt from his webinar presentation at CVIT Japan 2021, Dr. Rahul P. Sharma, MBBS, FRACP, Director of Structural Interventions at Stanford Medical Center, presents a case study that demonstrates the highly accurate multi-vessel FFR ...
By CathWorks
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XyloCor Therapeutics Doses Patients in Phase 1/2 Trial Evaluating Novel Gene Therapy XC001 in Refractory Angina
XyloCor Therapeutics today announced it has successfully dosed the first two patients in the EXACT Trial, a Phase 1/2 dose escalation trial evaluating the safety, tolerability and efficacy of its lead candidate XC001 in patients with refractory angina. The trial will enroll patients who are not responding to medication and are unsuitable for coronary artery bypass graft or percutaneous coronary ...
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Infraredx, a Nipro Company, Announces Enrollment of First Patient in EXPANSE PTCA study.
Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today the enrollment of the first patient in its EXPANSE PTCA study (NCT04985773) at the Cardiology Associates of North Mississippi in Tupelo, Mississippi. The study will be conducted in the United States with the objective to evaluate safety and effectiveness of the Lacrosse NSE ...
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Soundbite Medical Enters Into A License Agreement With VFLO Medical To Bring Its Products To Greater China
Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that it has entered into an exclusive license agreement with VFLO Medical (VFLO). Pursuant to the agreement, Soundbite has granted to VFLO an exclusive license for certain proprietary ...
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XyloCor Therapeutics Completes Oversubscribed $41.9 Million Series A Financing To Advance Novel Gene Therapy Pipeline For Coronary Artery Disease
Company closes additional $22.6 million in new financing Proceeds will fund initiation of new clinical trial for lead gene therapy candidate XC001 as adjunctive therapy for patients undergoing coronary artery bypass graft surgery XyloCor Therapeutics, a private clinical-stage biopharmaceutical company focused on the development of gene therapy for the significant unmet patient needs in ...
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MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions.
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes “The ...
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One-stop Mitochondria-focused Testing Services Targeting to Preclinical Studies of Cardiac Diseases
New York, United States—June 28, 2022—Creative Biogene offers one-stop mitochondria-focused testing services for the evaluation of a variety of cardiac diseases associated with mitochondrial dysfunction, which can provide insights and potential treatments for mitochondrial disorders in the preclinical stages. With its ready-to-use models and assays for cardiac diseases, customers can accurately ...
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CathWorks Announces Appointment of Ramin Mousavi as Chief Executive Officer and Board Member
CathWorks , a global leader of digital health innovation focused on helping patients with cardiovascular disease, today announced that Ramin Mousavi has been appointed Chief Executive Officer, effective June 21, 2021. Mr. Mousavi has also been appointed to the company’s Board of Directors. Mr. Mousavi succeeds Jim Corbett, who served as the company’s CEO since October 27, 2017. A ...
By CathWorks
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B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent Please ReX Drug Coated PTCA Balloon Catheter
B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial for the B. Braun SeQuent Please ReX Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation in late 2019. This announcement furthers the ...
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Reva Medical Presents 6-Month Results from Motiv BTK Pilot Study
REVA Medical, LLC. (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, is pleased to announce the presentation of the 6- month clinical outcomes data from a post market study of the Company’s MOTIV Below The Knee (BTK) scaffold. Prof. Thomas Rand, MD from the Klinik Floridsdorf Vienna, Austria presented the initial ...
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Soundbite Medical Announces Issuance Of A Fifth U.S. Patent Covering Novel Active Balloon Devices Intended For Plaque Modification Of Calcified Arteries
Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office has issued US patent No. 11,179,169, entitled “Device for delivering mechanical waves through a balloon catheter”. The ...
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Soundbite Medical Solutions Announces Issuance of a Fourth U.S. Patent Further Expanding Coverage of its Core Technology
Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office has issued US patent No. 11,065,645, entitled “Method and system for generating mechanical pulses”. The patent is directed to a ...
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Supira Medical, A Shifamed Portfolio Company, Closes $35M in Series B Financing
Company Appoints Seasoned Medtech Executive as President and CEO CAMPBELL, Calif., March 5, 2020 – Supira Medical, formed by Shifamed as part of its medical innovation hub, announced today the closing of $35M in Series B financing. Officially closed on February 25, the financing was led by Cormorant Asset Management with participation from The Capital Partnership (TCP), 415 CAPITAL, AMED ...
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XyloCor Therapeutics Names Alexander Gaidamaka, PhD, Senior Vice President of Technology, Manufacturing & Quality
XyloCor Therapeutics, a private clinical-stage biopharmaceutical company focused on the development of gene therapy for unmet needs in cardiovascular disease, strengthens its leadership team with the appointment of Alexander Gaidamaka, PhD, as Senior Vice President of Technology, Manufacturing & Quality. Dr. Gaidamaka brings a wealth of product development, regulatory and manufacturing ...
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Elucid Eyes Big Opportunity to Save Lives with Software Amidst Major Guideline Changes
BOSTON–(BUSINESS WIRE)–Elucid, a medical technology company developing AI software to enable cardiovascular disease detection, expects newly issued guidelines will be a catalyst for non-invasive image, revolutionizing the way patients with coronary artery disease are diagnosed and treated. In a highly anticipated document published online yesterday in Circulation and the Journal of ...
By Elucid
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Kardiolytics’ VCAST Technology Offers Non-Invasive and Safe Solution for Functional Evaluation of Coronary Disease, According to Recent Study in Cardiovascular Engineering and Technology
Our latest publication in Cardiovascular Engineering and Technology showcases the feasibility and functionality of our VCAST technology, a patented, AI-based medical system developed for non-invasive, clinical quantitative and qualitative analysis of CT-scan data, to assess the hemodynamic significance of coronary artery atherosclerotic stenosis. Using a ...
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Corindus Announces New Office Opening in Newton to Support Growth
Corindus, A Siemens Healthineers Company and a leading developer of precision vascular robotics, announced today the opening of its new headquarters at 275 Grove Street in Newton, Mass. Siemens Healthineers relocated the Corindus headquarters from its previous location in Waltham to accommodate company growth, doubling the size of the current location from 35,000 square feet to 77,000 square ...
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