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Catheter Device Articles & Analysis

34 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. ...

BySTEMart


Infection Control Resources to Mitigate Exposure Risks to Acinetobacter and Other Environmental Pathogens

Infection Control Resources to Mitigate Exposure Risks to Acinetobacter and Other Environmental Pathogens

CDC warns that those most at risk of infection include patients in hospitals, especially those who: are on breathing machines have devices such as catheters have open wounds from surgery are in intensive care units “Microorganisms have always presented a challenge to healthcare providers. ...

ByCochrane & Associates, LLC


Anuncia Medical Announces First Successful US Implant of the Company’s ReFlow Device with Sonolucent Cranial Plate to Noninvasively Visualize Flushing of Hydrocephalus Shunts

Anuncia Medical Announces First Successful US Implant of the Company’s ReFlow Device with Sonolucent Cranial Plate to Noninvasively Visualize Flushing of Hydrocephalus Shunts

Occlusion or clogging of the ventricular catheter by blood, debris, or tissue is the primary cause of shunt failure. ...

ByAnuncia Medical, Inc.


MedSource Labs Comment to USTR Promoting Supply Chain Resiliency

MedSource Labs Comment to USTR Promoting Supply Chain Resiliency

In his communication dated April 19, 2024, Kunelius emphasized MedSource Labs’ role in manufacturing essential medical devices, such as IV catheters and thermometers and made several proposals to enhance supply chain resilience. ...

ByMedsource Labs


Infection Control Resources to Safeguard Patients and Building Occupants from Acinetobacter and Other Pathogens

Infection Control Resources to Safeguard Patients and Building Occupants from Acinetobacter and Other Pathogens

Those most at risk of infection according to the CDC include patients in hospitals, especially those who: · are on breathing machines · have devices such as catheters · have open wounds from surgery · are in intensive care units · have prolonged hospital stays Infections of the blood, ...

ByCochrane & Associates, LLC


Infection Control Resources in Puerto Rico to Identify Acinetobacter and Other Microbial Pathogens

Infection Control Resources in Puerto Rico to Identify Acinetobacter and Other Microbial Pathogens

Those most at risk of infection according to the CDC include patients in hospitals, especially those who: · are on breathing machines · have devices such as catheters · have open wounds from surgery · are in intensive care units · have prolonged hospital stays “As recently as 2017, ...

ByCochrane & Associates, LLC


Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow Mini Flusher Device for Hydrocephalus Patients

Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow Mini Flusher Device for Hydrocephalus Patients

Intermountain Primary Children’s Hospital First in the Country to Implant this Next Generation FDA-Cleared Device Company Welcomes Vice President of Sales & Marketing, Mark Geiger, Who Lives with Hydrocephalus Anuncia Medical Inc. ...

ByAnuncia Medical, Inc.


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

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

This technology enables real-time accurate situational awareness of catheters and implantable devices in relation to complex anatomy. “I am honored to work with the innovative team at UC Davis Health,” said EchoPixel founder and CEO Sergio Aguirre. ...

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

Over 90% met the primary endpoint of complete or near-complete thrombus extraction and there was only one device-related serious adverse event. There were no reports of valve damage, vessel damage, or acute kidney injury (AKI). ...

ByInari Medical


Linear Health Sciences Announces Issuance of First US Patent

Linear Health Sciences Announces Issuance of First US Patent

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 comes at an exciting time for our company, as many assets are evolving from speculative to tangible,” said founder and Chief Executive Officer Ryan Dennis, M.D. “The breadth of our ...

ByLinear Health Sciences


Procyrion Selects Former Abbott/St. Jude Medical Group President Dr. Eric S. Fain as CEO

Procyrion Selects Former Abbott/St. Jude Medical Group President Dr. Eric S. Fain as CEO

Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, has named Eric S. ...

ByProcyrion, Inc.


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 ...

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

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges ...

ByPAVmed Inc.


Bluegrass Vascular Announces Publication Reporting Long-term data following facilitation of HeRO graft placement using the Surfacer System

Bluegrass Vascular Announces Publication Reporting Long-term data following facilitation of HeRO graft placement using the Surfacer System

“The ability to utilize the Surfacer System to help facilitate the placement of the HeRO graft as a means of permanent arteriovenous (AV) access and avoid the placement of a femoral catheter reinforces the clinical value the device offers to patients on hemodialysis ...

ByBluegrass Vascular Technologies, 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 ...

ByReflow Medical, Inc.


Q’Apel Medical Welcomes Thomas Berryman, Chief Financial Officer

Q’Apel Medical Welcomes Thomas Berryman, Chief Financial Officer

Before Walrus came along, balloon-based variable stiffness catheters brought all manner of technological constraints. Not anymore. ...

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. ...

ByNeurescue


The Ultimate List of Attractive MedTech M&A Targets

The Ultimate List of Attractive MedTech M&A Targets

The Peregrine System Kit is comprised of an infusion catheter and dehydrated alcohol. The device is used in a minimally invasive procedure with the goal of deactivating the nerves surrounding the renal arteries and thereby reducing blood pressure. ...

ByAnuncia Medical, Inc.


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., 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

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. ...

ByInfraredx, Inc.


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

Habib Frost and headquartered in Copenhagen, Denmark, aims to bring that survival rate to 9 out of 10 people with its new device. Currently under U.S. Food and Drug Administration review, the Neurescue device is designed to increase blood flow to the brain and heart during life-threatening emergencies. ...

ByNeurescue

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