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CE Mark

Endostart wins CE mark to bring magnetic balloon tech to enteroscopy

October 11, 2024 By Sean Whooley

EndoStart Endorail

Endostart announced today that it received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety in endoscopic procedures. The technology utilizes a magnetic balloon system to enhance control of the endoscope in both the small and large bowel. It … [Read more...] about Endostart wins CE mark to bring magnetic balloon tech to enteroscopy

Filed Under: Balloons, Catheters, CE Mark, Endoscopes, Regulatory, Technologies & Devices Tagged With: Endostart

Penumbra wins CE mark for computer-assisted thrombectomy tech

September 16, 2024 By Sean Whooley

Penumbra Lightning Flash 2.0 Lightning Bolt computer-assisted thrombectomy system (1)

Penumbra (NYSE:PEN) announced today that it received CE mark approval for its computer-assisted vacuum thrombectomy (CAVT) technologies. The Lightning Flash 2.0 and Lightning Bolt 7 offerings from the Alameda, California-based company both picked up European approval. Penumbra said approval makes its Lightning products the only CAVT systems … [Read more...] about Penumbra wins CE mark for computer-assisted thrombectomy tech

Filed Under: Applications, Catheters, CE Mark, Neurology, Regulatory, Technologies & Devices Tagged With: penumbra

AngioDynamics wins CE Mark for AlphaVac F18

May 23, 2024 By Danielle Kirsh

angiodynamics-alphavac

  AngioDynamics announced this week that it received CE Mark approval for its AlphaVac F18 system, which treats pulmonary embolism and removes thrombi and emboli. AlphaVac F18 is an emergent first-line device the company designed for the non-surgical removal of thromboemboli from the pulmonary arteries and for the treatment of pulmonary … [Read more...] about AngioDynamics wins CE Mark for AlphaVac F18

Filed Under: Catheters, CE Mark, Regulatory, Technologies & Devices Tagged With: AngioDynamics

The top catheter-based innovation news stories of 2024 — so far

April 18, 2024 By Danielle Kirsh

Catheter innovations have had a remarkable year so far, with many receiving regulatory approval as they prepare to enter the market. The pulsed field ablation market heated up in 2023 and continues to make waves this year with more companies entering the space. Intravascular lithotripsy is having its moment as well – Shockwave Medical was … [Read more...] about The top catheter-based innovation news stories of 2024 — so far

Filed Under: 510(k), Applications, Business, Cardiology, Catheters, CE Mark, Heart valves, Pulsed Field Ablation, Regulatory, Technologies & Devices Tagged With: Abbott, Biosense Webster, FastWave Medical, Reflow Medical, Stereotaxis

Getinge wins European approval for covered stent system

April 11, 2024 By Sean Whooley

Getinge Advanta V12 covered stent

Getinge announced today that it received EU MDR certification for its Advanta V12 covered stent system for patients with aortoiliac occlusive disease (AIOD). The balloon-expandable covered stent's indication aligns with AIOD, which includes treating lesions at the aortic bifurcation. Getinge said EU MDR certification highlights its dedication … [Read more...] about Getinge wins European approval for covered stent system

Filed Under: Applications, Balloons, Cardiology, CE Mark, Regulatory, Stents, Technologies & Devices Tagged With: Getinge

PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device

March 11, 2024 By Danielle Kirsh

pulsecath logo

PulseCath this week announced it received CE mark approval for its iVAC 2L percutaneous mechanical circulatory support device. The iVAC 2L device helps facilitate high-risk percutaneous coronary interventions. PulseCath designed it to pump blood from the left ventricle to the aorta in synchronization with the natural rhythm of the patient's … [Read more...] about PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device

Filed Under: Catheters, CE Mark Tagged With: PulseCath

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