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Catheter Patency Device Articles & Analysis

18 news found

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers ...

BySTEMart


1st MitraClip Procedure Guided by 4D Performed at UC Davis Health

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 ...

ByEchoPixel, Inc.


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 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 ...

ByInari Medical


Enrollment Completed In Reflow Medical’s DEEPER OUS Clinical Trial

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 ...

ByReflow Medical, Inc.


Lucid Diagnostics’ Laboratory Executes Participating Provider Agreement with MediNcrease Health Plans

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 ...

ByPAVmed Inc.


Reflow Medical Receives Approval In Japan For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease

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 ...

ByReflow Medical, Inc.


Q’Apel Medical Welcomes Thomas Berryman, Chief Financial Officer

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 ...

ByQ`Apel Medical Inc.


Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

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 ...

ByNeurescue


1 out of 10 survive cardiac arrest, a new device under FDA review hopes to change that

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, ...

ByNeurescue


Bluegrass Vascular Announces Publication of Surfacer System SAVE Registry Results

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 ...

ByBluegrass Vascular Technologies, Inc.


Medtronic to Acquire Avenu Medical

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 ...

ByMedtronic


Second Heart Assist to Unveil Updated Wireless Power Design at ASAIO Annual Meeting

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 ...

BySecond Heart Assist, Inc.


Thermedical Announces FDA Breakthrough Device Designation

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 ...

ByThermedical, Inc.


World MRSA Awareness Month and Protecting the Residents of Puerto Rico from Microbial Exposure Risks

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 ...

ByCochrane & Associates, LLC


Procyrion Names AV Edidin, Ph.D., as Senior Vice President of Development and Manufacturing

Procyrion Names AV Edidin, Ph.D., as Senior Vice President of Development and Manufacturing

Procyrion, Inc., a clinical-stage medical device company developing the Aortix™ system, a percutaneous blood pump initially targeted for treating patients with heart failure and worsening kidney function (cardiorenal syndrome), announced the appointment of Av Edidin, Ph.D., as Senior Vice President of Development and Manufacturing. In this role, Edidin will lead and oversee product ...

ByProcyrion, Inc.


Procyrion Named Most Innovative Heart Pump Technology In 2018 Global Healthcare and Pharmaceutical Awards

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 ...

ByProcyrion, Inc.


Brain emergency averted at the push of a button

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 ...

ByAnuncia Medical, Inc.


CrossBay Medical Announces FDA and CE Mark Marketing Authorizations for its IVF Embryo Transfer Catheter Set

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 ...

ByCrossBay Medical

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