catheter device News
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Soundbite Medical Solutions Announces Issuance of Two New U.S. Patent Further Expanding Coverage of its Shock Wave Technology
Soundbite Medical Solutions Inc. (SBMS), a medical device company leveraging its proprietary shock wave technology for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office has issued two additional US patents. Patent No. 11,419,619, entitled “Method and system for treating ...
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CrossBay Medical Announces FDA and CE Mark Marketing Authorizations for its IVF Embryo Transfer Catheter Set
SAN FRANCISCO, May 17, 2017 /PRNewswire/ -- CrossBay Medical, Inc., today announced receipt of United States Food and Drug Administration (FDA) clearance of its product, the CrossBay IVF Embryo Transfer Catheter Set. The device has also received clearance to commercialize the product in Europe by obtaining its CE mark. The product is intended for ultrasound-guided transfer of embryos into the ...
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Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s NEURESCUE® device for temporary occlusion of large vessels, including patients requiring emergency ...
By Neurescue
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Brain emergency averted at the push of a button
A Boston neurosurgeon recently avoided doing emergency brain surgery on a young patient just by pressing on a new device. The Alivio ReFlow ventricular system was embedded beneath the scalp of the unidentified hydrocephalus patient. Comprised of a subcutaneous “flusher” component and a ventricular catheter, the device has a “relief membrane” backup feature at the ...
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Q’Apel Medical Welcomes Thomas Berryman, Chief Financial Officer
Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, is pleased to announce and welcome Thomas Berryman as Chief Financial Officer. Tom has extensive experience in bringing venture funded medical technology companies from initial startup through product commercialization, revenue ...
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Thermedical Announces FDA Breakthrough Device Designation
WALTHAM. Mass.. May 19,2020 - Thermedicak a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT): today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter. The FDA Breakthrough Devices Program is intended to help ...
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Enrollment Completed In Reflow Medical’s DEEPER OUS Clinical Trial
Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the company’s Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease. 106 patients have now been enrolled in the prospective, nonrandomized trial in multiple centers in Europe and New Zealand. Intended ...
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1 out of 10 survive cardiac arrest, a new device under FDA review hopes to change that
KEY POINTS Cardiac arrest is one of the leading causes of death in the U.S. and globally. It has a survival rate of 1 in 10 people with current treatment. The Neurescue device is designed to increase blood flow to the brain and heart during life-threatening emergencies such as cardiac arrest. Cardiac arrest is one of the leading causes of death around the world, ...
By Neurescue
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Procyrion Named Most Innovative Heart Pump Technology In 2018 Global Healthcare and Pharmaceutical Awards
Houston medical device developer Procyrion Inc. today announced they have won the Most Innovative Heart Pump Technology award in the 2018 Global Healthcare and Pharmaceutical Awards for their device, Aortix™, a catheter-deployed circulatory support device designed initially to address cardiorenal syndrome in heart failure patients. The award celebrates the contributions made by ...
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Reflow Medical Receives Approval In Japan For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease
Reflow Medical, Inc., a California- based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO Catheter in Japan. The Wingman Catheter crosses peripheral ...
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1st Patient treated with Vetex Thrombectomy Catheter
Vetex™ Medical Ltd., an innovator in deep vein thrombosis (DVT) treatment, announced it’s first patient on December 18th, 2018, treated in the VETEX (Venous Thrombus Extraction) Study, a first-in-man, multicenter study of the Vetex™ Thrombectomy Catheter. The Vetex device is the first DVT device to combine rotational and grasping action to quickly and gently remove large volumes ...
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1st MitraClip Procedure Guided by 4D Performed at UC Davis Health
Sacramento, CA – The first MitraClip procedure using EchoPixel’s Holographic Therapy Guidance (HTG) was performed by Structural Heart Physicians at UC Davis Health. The image acquisition was led by Edris Aman M.D. while the procedure was performed and HTG guidance utilized by Gagan Singh, M.D., director, Cardiovascular Research Unit. MitraClip is a procedure that approximates ...
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Lucid Diagnostics’ Laboratory Executes Participating Provider Agreement with MediNcrease Health Plans
Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”, the “Company”) a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), today announced that its wholly-owned CLIA-certified and CAP-accredited laboratory, LucidDx Labs Inc. (“LucidDx Labs”), has entered into a ...
By PAVmed Inc.
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Bluegrass Vascular Announces Publication of Surfacer System SAVE Registry Results
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of the results from the company’s prospective, multicenter SAVE (Surfacer® System to Facilitate Access in VEnous Occlusions) Registry in the Journal of Vascular and Interventional ...
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Inari Medical Announces In-hospital and 30-day Outcomes from the Fully Enrolled CLOUT Registry and Results from Propensity-Score Matched Comparison of CLOUT vs. ATTRACT
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive in-hospital and 30-day outcomes from the fully-enrolled 500-patient CLOUT registry. The company also reported positive results from a propensity-matched comparison of patients ...
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Medtronic to Acquire Avenu Medical
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the planned acquisition of Avenu Medical, a privately held medical device company based in San Juan Capistrano, Calif. focused on the endovascular (minimally invasive) creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. Terms of the transaction were not ...
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World MRSA Awareness Month and Protecting the Residents of Puerto Rico from Microbial Exposure Risks
The month of October has been designated as World MRSA Awareness Month. The recognition is meant to draw attention to the seriousness of this superbug infection and spread information on ways to prevent its proliferation. Methicillin-resistant Staphylococcus aureus (MRSA) is a type of staph bacteria that can be found on many people’s skin or even in their nose. For those who develop a ...
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Second Heart Assist to Unveil Updated Wireless Power Design at ASAIO Annual Meeting
Salt Lake City, Utah, May 7th, 2020 – Second Heart Assist, the innovative developers of the world’s first percutaneous placed true aortic stent based circulatory assist pumps, are delighted to announce that they will provide a brief update on their breakthrough wireless powered chronic implant circulatory assist device, at the upcoming ASAIO tele-conference June 10-13, 2020. The ...
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Linear Health Sciences Announces Issuance of First US Patent
OKLAHOMA CITY – Linear Health Sciences today announced that the United States Patent and Trademark Office has issued the company’s first patent related to its flagship product, the Orchid Safety Release Valve™. US Patent No. 9,861,805 B2 covers wide-ranging claims behind the needless connector for use in medical access devices such as IV catheters. “The patent issuance ...
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MedSource Labs Comment to USTR Promoting Supply Chain Resiliency
Dave Kunelius, President of MedSource Labs, recently addressed the Honorable Katherine Tai, United States Trade Representative, as part of an ongoing dialogue with local and national policymakers concerning challenges in the medical supply chain. In his communication dated April 19, 2024, Kunelius emphasized MedSource Labs’ role in manufacturing essential medical devices, such as IV ...
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