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Medical Tubing and Extrusion

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Chris Newmarker

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

Cook Medical angiographic catheter recall is Class I

June 25, 2025 By Chris Newmarker

Cook Medical beacon tip catheters

The FDA has designated Cook Medical's recall of its Beacon Tip 5.0 Fr angiographic catheter as Class I, the most serious level. Users reported tip separation occurring both before and during patient contact, according to an FDA notice published today. As a result, catheter fragmentation and embolization might occur with the catheters involved in … [Read more...] about Cook Medical angiographic catheter recall is Class I

Filed Under: Applications, Cardiology, Catheters, Recalls, Regulatory, Technologies & Devices Tagged With: Cook Medical

Luma Vision wins FDA clearance for cardiac visualization platform

April 17, 2025 By Chris Newmarker

This is a Luma Vision marketing image of its Verafeye catheter-based cardiac imaging system.

Luma Vision recently announced that the FDA has cleared its Verafeye catheter-based cardiac imaging system. The company — based in Dublin, Ireland, and Munich, Germany — describes Verafeye as a novel catheter-based imaging system that provides real-time, two and four-dimensional, 360-degree visualization, enhancing clinician precision and … [Read more...] about Luma Vision wins FDA clearance for cardiac visualization platform

Filed Under: 510(k), Applications, Cardiology, Regulatory Tagged With: Luma Vision

Confluent Medical Technologies announces Ultra Polyimide

April 7, 2025 By Chris Newmarker

This is the logo of Confluent Medical Technologies.

NEWS RELEASE: Confluent Medical Technologies announces Ultra Polyimide Confluent unveils material breakthrough that delivers twice the strength of traditional polyimide. Scottsdale, Arizona – Confluent Medical Technologies (Confluent), a leading medical device and materials science contract manufacturer specializing in polymer and metal … [Read more...] about Confluent Medical Technologies announces Ultra Polyimide

Filed Under: Materials, Plastics, Technologies & Devices Tagged With: Confluent Medical Technologies

VVT Medical plans to go public on Toronto exchange

March 28, 2025 By Chris Newmarker

This is a VVT Medical marketing image of the ScleroSafe system.

VVT Medical, a developer of minimally invasive treatments for venous insufficiency, announced that it has received conditional approval from the TSXv to list its common shares. The Kfar Saba, Israel–based company has already secured $6.5 million in funding toward its listing and seeks to reach at least $8 million in total financing. DXI Capital … [Read more...] about VVT Medical plans to go public on Toronto exchange

Filed Under: Applications, Business, Cardiology Tagged With: VVT Medical

Stereotaxis Magic ablation catheter is now CE mark approved

January 27, 2025 By Chris Newmarker

Stereotaxis Magic ablation catheter

Stereotaxis (NYSE:STXS) said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter. The St. Louis–based robotic surgery company submitted Magic for both CE mark and FDA approval nearly a year ago; it still awaits an FDA nod in the U.S. Magic performs cardiac ablation procedures to treat … [Read more...] about Stereotaxis Magic ablation catheter is now CE mark approved

Filed Under: Applications, Cardiology, Catheters, CE Mark, Regulatory, Surgical Robotics, Technologies & Devices Tagged With: Stereotaxis

Imperative Care wins FDA clearance for Zoom stroke treatment

January 27, 2025 By Chris Newmarker

This is an Imperative Care marketing image of an .088-in. catheter for use with its Zoom comprehensive stroke thrombectomy system .

Imperative Care announced today that it has secured FDA 510(k) clearance for its Zoom comprehensive stroke thrombectomy system. According to Campbell, California–based Imperative Care, the Zoom system is the first such system to include large-bore .088-in. catheters indicated for both access and aspiration when used with one of the company's … [Read more...] about Imperative Care wins FDA clearance for Zoom stroke treatment

Filed Under: 510(k), Applications, Cardiology, Catheters, Neurology, Regulatory, Technologies & Devices Tagged With: Imperative Care

Circa Scientific has first cases with CrossWise RF transseptal access system

January 14, 2025 By Chris Newmarker

This is a Circa Scientific marketing illustration of its CrossWise RF transseptal access system.

Circa Scientific this week announced the launch of its CrossWise RF transseptal access system, designed to precisely puncture the heart's septal wall. The FDA-cleared system delivers radiofrequency energy directly to the tip of a shapeable, radiopaque cannula, according to Englewood, Colorado–based Circa Scientific. The company says the design … [Read more...] about Circa Scientific has first cases with CrossWise RF transseptal access system

Filed Under: Applications, Business, Cardiology, Catheters, Technologies & Devices Tagged With: Circa Scientific

Relief Cardiovascular raises $12M for smart transcatheter implant

January 10, 2025 By Chris Newmarker

This is the logo of Relief Cardiovascular.

Relief Cardiovascular recently announced that it closed a $12 million Series A round to help initiate a first-in-human feasibility study for its Relief System. Costa Mesa, California–based Relief Cardiovascular, an inQB8 Medical Technologies portfolio company, describes the Relief System as a transcatheter smart implant designed to monitor and … [Read more...] about Relief Cardiovascular raises $12M for smart transcatheter implant

Filed Under: Applications, Business, Cardiology, Catheters Tagged With: Relief Cardiovascular

Medtronic gets CE mark for Harmony transcatheter pulmonary valve

January 6, 2025 By Chris Newmarker

This is a Medtronic image of the Harmony transcatheter pulmonary valve (TPV) system .

Medtronic today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system. About 1.3 children around the world each year are born with congenital heart disease, according to the Minneapolis-based nonprofit Children's HeartLink. The Harmony system provides a minimally invasive alternative to open-heart surgery for … [Read more...] about Medtronic gets CE mark for Harmony transcatheter pulmonary valve

Filed Under: Applications, Cardiology, CE Mark, Heart valves, Regulatory, Technologies & Devices Tagged With: medtronic

Terumo launches R2P NaviCross peripheral support catheter in US

December 4, 2024 By Chris Newmarker

This is a Terumo marketing image of its R2P NaviCross peripheral support catheter.

Terumo is further boosting its radial-to-peripheral portfolio with the U.S. launch of its R2P NaviCross peripheral support catheter. The Japanese medtech giant's Terumo Interventional Systems division designed the R2P NaviCross catheter for optimized performance in R2P procedures, which involve accessing the radial artery around the wrist in … [Read more...] about Terumo launches R2P NaviCross peripheral support catheter in US

Filed Under: Applications, Cardiology, Catheters, Technologies & Devices Tagged With: Terumo

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