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Balloon Pta Balloon Catheter Articles & Analysis

29 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


CD Bioparticles Introduces Hydrophilic Coatings for Medical Applications

CD Bioparticles Introduces Hydrophilic Coatings for Medical Applications

CD Bioparticles, a leading manufacturer and supplier of various drug delivery products and services, recently introduced hydrophilic coatings and related services for medical applications, which can be used within interventional medical devices of the cardiovascular, circulatory, nervous, urinary, and vascular system. Functional medical coatings are a class of interface materials applied to the ...

ByCD Bioparticles


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.


Infraredx, a Nipro Company, Announces Enrollment of First Patient in EXPANSE PTCA study.

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 ...

ByInfraredx, Inc.


Leonhardt’s Launchpads Accelerator to Showcase Eight Innovation Assets and Startups At 2022 Demo Day

Leonhardt’s Launchpads Accelerator to Showcase Eight Innovation Assets and Startups At 2022 Demo Day

Irvine, Calif., Nov. 16th, 2021 /PRDistribution/ — Leonhardt’s Launchpads announced today that they will showcase eight graduates of their innovation and startup launch accelerator program on a Demo Day. The event will occur both in person and virtually on Friday, January 14, 2022, at 3 pm PT at UCI Research Park, University Lab Partners, 5270 California Avenue, Suite 300, Irvine, CA ...

BySecond Heart Assist, Inc.


Q’Apel Medical Launches Armadillo – A New Radial Artery Access Platform to Meet the Needs of Physicians and Patients

Q’Apel Medical Launches Armadillo – A New Radial Artery Access Platform to Meet the Needs of Physicians and Patients

Nationally there is a trend moving towards radial artery access versus femoral artery access for endovascular procedures and Q’Apel Medical is leading the way. Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today the launch of the Armadillo Radial Access ...

ByQ`Apel 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.


Q’Apel Medical Announces Move to New Headquarters Facility in Fremont, CA

Q’Apel Medical Announces Move to New Headquarters Facility in Fremont, CA

New 35,000 square foot Facility will support the company’s growth and OUS expansion Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today that it will relocate its existing headquarters into a new building at 4245 Technology Dr, Fremont, CA, 94538. The 35,000 ...

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


Q’Apel Medical Welcomes Jodie Fam, Vice President and General Manager, International

Q’Apel Medical Welcomes Jodie Fam, Vice President and General Manager, International

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 Jodie Fam as Vice President and General Manager, International. Jodie will be responsible for the leadership and development of International Sales for Q’Apel. Jodie brings more than 20 ...

ByQ`Apel Medical Inc.


Neurescue Announces Appointment of Medtronic Veteran Mette-Marie Harild to Company’s Board of Directors

Neurescue Announces Appointment of Medtronic Veteran Mette-Marie Harild to Company’s Board of Directors

COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a clinical-stage medical device company bringing to market the world’s first computer-aided balloon catheter for aortic occlusion, today announced that medical device industry veteran Mette-Marie Harild has been appointed to the Neurescue board of directors. Most recently the regional vice president of Medtronic’s largest sub-region in ...

ByNeurescue


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

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 ...

ByInfraredx, Inc.


Q’Apel Medical Raises $22 Million to Grow Highly Innovative Neurovascular Access Platform & Scott Huennekens joins Board of Directors.

Q’Apel Medical Raises $22 Million to Grow Highly Innovative Neurovascular Access Platform & Scott Huennekens joins Board of Directors.

Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today it has raised $22 Million in Series C funding. The round included River Cities Capital, Soleus Capital and incumbent investor, Research Corporation Technologies (RCT). Scott Huennekens, former Chairman, CEO and ...

ByQ`Apel Medical Inc.


MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions.

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 ...

ByConcept Medical Inc.


Kardium performs first cases with the Globe® Positioning System

Kardium performs first cases with the Globe® Positioning System

VANCOUVER, British Columbia – Kardium is pleased to announce the first clinical use of the Globe Positioning System (GPS™) – the new 3D mapping and navigation feature of its flagship product, the Globe® Mapping and Ablation System. The Globe System is the most complete solution for the treatment of atrial fibrillation (AF) – the world’s most common heart rhythm ...

ByKardium Inc.


APBI with VeraForm® & SAVI® Brachytherapy: Marking for the Unpredictable

APBI with VeraForm® & SAVI® Brachytherapy: Marking for the Unpredictable

Our Medical Director of the Oncology Breast Program, Dr. Beth DuPree, was first in the U.S. to adopt VeraForm, a continuous, radiopaque 3D tissue marker. Within months, its utility led to quick integration into our program’s standard daily practice. Like all centers today, patient satisfaction is a focal point and to date, we have seen no complications or toxicities by any criteria (e.g., ...

ByVidera Surgical Inc.


Q’Apel Medical announces first-in-human case with Wahoo.

Q’Apel Medical announces first-in-human case with Wahoo.

Q’Apel Medical, a neurovascular medical device company, today announced it successfully completed the first-in-human case with the Wahoo access catheter, utilizing the next-generation SelectFlex technology. The procedure was performed by Raymond Turner, M.D., at Prisma Health in Greenville, South Carolina. The Wahoo access catheter contains proprietary SelectFlex variable stiffness ...

ByQ`Apel Medical Inc.


Concept Medical is Granted CE Certification for Sirolimus Coated MagicTouch Group of Products.

Concept Medical is Granted CE Certification for Sirolimus Coated MagicTouch Group of Products.

The CE certified products/brands are as listed below: MagicTouch – PTA (Sirolimus Coated PTA Balloon Catheter) for peripheral arterial disease MagicTouch – ED (Sirolimus Coated Balloon Catheter) for Erectile Dysfunction MagicTouch – AVF (Sirolimus Coated ...

ByConcept Medical Inc.


Howard Leonhardt and Alex Richardson of Second Heart Assist discuss regenerating hearts and novel medical devices

Howard Leonhardt and Alex Richardson of Second Heart Assist discuss regenerating hearts and novel medical devices

During their recent visit to Victoria BC for lab testing services, Second Heart Assist Chairman and CEO, Howard Leonhardt (HL), and VP of Engineering & Product Development, Alex Richardson (AR), spoke with ViVitro Lab and Interim General Manager, Rob Fraser (RF), about their work at Second Heart Assist, and Leonhardt Ventures. RF: You both have a long history with medical devices. Please ...

BySecond Heart Assist, Inc.


Q’Apel Medical announces FDA clearance for Walrus Balloon Guide Catheter.

Q’Apel Medical announces FDA clearance for Walrus Balloon Guide Catheter.

In the neurovascular space where speed, reliability, and performance are so critical to patient outcomes, physicians and patients demand that innovative technologies are best-in-class. The walrus BGC, with its 087 ID, marks a big step forward in balloon guide catheter technology and for stroke patients worldwide. “I expect its introduction will be welcomed by neurovascular physicians ...

ByQ`Apel Medical Inc.

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