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Medical Tubing and Extrusion

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Sean Whooley

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Anaconda Biomed wins CE mark for funnel catheter

June 18, 2025 By Sean Whooley

Anaconda Biomed ANA5 funnel catheter in vessel (1)

Anaconda Biomed announced today that it received CE mark approval to commercialize its ANA5 funnel catheter in Europe. The company designed ANA5, a next-generation funnel catheter, to optimize mechanical thrombectomy. It maximizes clot capture with its vessel-matching diameter funnel. Simultaneously, it enables antegrade flow arrest and offers the … [Read more...] about Anaconda Biomed wins CE mark for funnel catheter

Filed Under: Applications, Catheters, CE Mark, Neurology, Regulatory, Technologies & Devices Tagged With: Anaconda Biomed, nitinol

FDA adds Gradient denervation tech to advisory program

June 18, 2025 By Sean Whooley

Gradient Denervation Technologies logo

Gradient Denervation Technologies announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. The company expects its acceptance into … [Read more...] about FDA adds Gradient denervation tech to advisory program

Filed Under: Applications, Cardiology, Catheters, Regulatory, Technologies & Devices Tagged With: fda, Gradient Denervation Technologies

Penumbra completes enrollment in pulmonary embolism trial

June 16, 2025 By Sean Whooley

Penumbra Lightning Flash thrombectomy system (1)

Penumbra (NYSE:PEN) announced today that it completed enrollment in the STORM-PE trial of its Lightning Flash system. STORM-PE evaluates Lightning Flash computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation. It pits that against anticoagulation alone in the treatment of acute intermediate-high risk pulmonary embolism (PE). The study … [Read more...] about Penumbra completes enrollment in pulmonary embolism trial

Filed Under: Catheters, Technologies & Devices Tagged With: penumbra

FDA expands clearance for Inquis Medical’s Aventus thrombectomy system

June 16, 2025 By Sean Whooley

Inquis Medical Logo (1)

Inquis Medical announced today that the FDA granted expanded 510(k) clearance for its Aventus thrombectomy system. The expanded clearance means Aventus now has an indication to treat pulmonary embolism (PE). It comes around a month after the Menlo Park, California–based company shared positive study data for Aventus in PE. The study successfully … [Read more...] about FDA expands clearance for Inquis Medical’s Aventus thrombectomy system

Filed Under: 510(k), Regulatory, Technologies & Devices Tagged With: Inquis Medical

Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe

June 13, 2025 By Sean Whooley

Philips intracardiac echocardiography VeriSight Pro 3D ICE catheter

Philips today announced the first procedures in Europe with its recently launched VeriSight Pro 3D ICE catheter. Doctors at the German University Medical Center Mainz and Robert Bosch Hospital in Stuttgart completed the first procedures in Europe after the intracardiac echocardiography (ICE) catheter following its launch across the continent last … [Read more...] about Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe

Filed Under: Applications, Cardiac Implants, Cardiology, Catheters, Technologies & Devices Tagged With: Philips

Teleflex has positive Arrow catheter data

June 13, 2025 By Sean Whooley

Teleflex logo

Teleflex reports new findings from a study showing the efficacy of its Arrow chlorhexidine-impregnated central venous catheters (CVCs).  The prospective study cohort included more than 6,670 patients from 12 intensive care units (ICUs). It spanned eight hospitals across India, Malaysia, Papua New Guinea, Colombia, Egypt and Turkey. Wayne, … [Read more...] about Teleflex has positive Arrow catheter data

Filed Under: Catheters, Technologies & Devices Tagged With: teleflex

Aortyx raises $16M for bioresorbable aortic patch

June 12, 2025 By Sean Whooley

Aortyx bioresorbable aortic patch device

Aortyx announced today that it brought in $16 million (€13.8 million) to support its bioresorbable aortic patch technology. The company expects the funding to help bring the patch to first-in-human tests within two years. Funding came from Ship2B Ventures, through its BSocial Impact Fund (supported by Banco Sabadell, the EIF, and AXIS), and Clave … [Read more...] about Aortyx raises $16M for bioresorbable aortic patch

Filed Under: Applications, Business, Cardiac Implants, Cardiology, Catheters, Technologies & Devices Tagged With: Aortyx

Atraverse raises $29.4M for left-heart access device

June 10, 2025 By Sean Whooley

Atraverse Medical Logo

Atraverse Medical announced today that it closed a $29.4 million follow-on financing round to help accelerate growth. The San Diego-based company secured an oversubscribed seed funding round worth $12.5 million last year. This follow-on funding builds on that round, which helped to obtain FDA 510(k) clearance and begin the early rollout of … [Read more...] about Atraverse raises $29.4M for left-heart access device

Filed Under: Applications, Business, Cardiology, Catheters, Technologies & Devices Tagged With: Atraverse Medical

CoreMap wins FDA IDE for ablation mapping tech

May 29, 2025 By Sean Whooley

CoreMap updated Logo (1)

CoreMap announced that it received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S. The study aims to evaluate the safety and effectiveness of the CoreMap endocardial EP mapping system in patients with AFib. It looks at both persistent AFib and long-standing persistent AFib. The company says … [Read more...] about CoreMap wins FDA IDE for ablation mapping tech

Filed Under: Applications, Cardiology, Catheters, Pulsed Field Ablation, Regulatory, Technologies & Devices Tagged With: coremap

BD to begin real-world atherectomy registry for PAD

May 28, 2025 By Sean Whooley

BD Rotarex Thrombectomy Atherectomy system peripheral artery disease PAD (1)

BD [WtwhTicker symbol="BDX"](NYSE: BDX)[/WtwhTicker] announced today that it plans to initiate a patient data registry for its Rotarex atherectomy system. The registry aims to measure real-world outcomes for patients with peripheral artery disease (PAD). XTRACT, a multi-center, single-arm, post-market registry assesses Rotarex's clinical … [Read more...] about BD to begin real-world atherectomy registry for PAD

Filed Under: Catheters, Technologies & Devices Tagged With: BD

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