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Medical Tubing and Extrusion

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Sean Whooley

EvoEndo CEO to leave, replacement named

April 6, 2023 By Sean Whooley

evoendo

EvoEndo announced today announced a new CEO and COO along with the departure of previous CEO Heather Underwood. Denver-based EvoEndo, which develops transnasal endoscopy technology, named Jonathan Hartmann as president and CEO. It appointed Ryan Hartman to the COO position. Underwood intends to remain with the company through April to support … [Read more...] about EvoEndo CEO to leave, replacement named

Filed Under: Endoscopes Tagged With: EvoEndo, personnel-moves

Cook Medical, Vizient ink contract for endoscopy devices

April 3, 2023 By Sean Whooley

Cook Medical

Cook Medical announced today that it received a contract with Vizient covering the company's endoscopy devices. The contract enables Cook to continue offering its endoscopy devices at negotiated pricing terms to Vizient members. “We are honored to have been chosen as an Endoscopy contracted supplier with Vizient," said Rick Simms, Cook … [Read more...] about Cook Medical, Vizient ink contract for endoscopy devices

Filed Under: Endoscopes Tagged With: Cook Medical, Vizient

Getinge’s Datascope has its second Class I recall in a month

March 31, 2023 By Sean Whooley

Datascope Getinge Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump

The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The … [Read more...] about Getinge’s Datascope has its second Class I recall in a month

Filed Under: Balloons, Recalls, Regulatory Tagged With: Datascope, Getinge

Study backs LimFlow system for treating chronic limb-threatening ischemia

March 31, 2023 By Sean Whooley

LimFlow system treating chronic limb-threatening ischemia

LimFlow announced that new study results demonstrated statistically significant survival with its chronic limb-threatening ischemia (CLTI) treatment. Paris-based LimFlow’s results came from its Promise II U.S. pivotal trial. They were published in today’s issue of the New England Journal of Medicine (NEJM). Data demonstrated 66% amputation-free … [Read more...] about Study backs LimFlow system for treating chronic limb-threatening ischemia

Filed Under: Catheters Tagged With: LimFlow

Gore enrolls first U.S. patient in vascular stent trial

March 28, 2023 By Sean Whooley

Gore Viafort vascular stent

  W.L. Gore & Associates announced that it enrolled the first U.S. patient in a clinical trial for its Viafort vascular stent. Gore aims to evaluate Viafort for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without iliofemoral obstruction. The prospective, non-randomized, multi-center, single-arm study … [Read more...] about Gore enrolls first U.S. patient in vascular stent trial

Filed Under: Stents Tagged With: gore, W.L. Gore & Associates

Surmodics targets FDA premarket approval for drug-coated balloon in Q4

March 28, 2023 By Sean Whooley

surmodics logo

Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is … [Read more...] about Surmodics targets FDA premarket approval for drug-coated balloon in Q4

Filed Under: Balloons, Catheters, Regulatory Tagged With: fda, surmodics

Some hospitalized patients’ infections may develop from their own bacteria in catheters

March 27, 2023 By Sean Whooley

A.baumannii bacteria that can develop in catheters

Researchers in Missouri discovered evidence of infections forming from hospitalized patients' own bacteria in catheters. Studying mice, researchers at Washington University School of Medicine in St. Louis discovered that urinary tract infections (UTIs) can arise after sterile catheter tube insertion into the urinary tract. This can occur even … [Read more...] about Some hospitalized patients’ infections may develop from their own bacteria in catheters

Filed Under: Uncategorized Tagged With: bacteria, Washington University in St. Louis, Washington University School of Medicine in St. Louis

Getinge’s Datascope has another serious intra-aortic balloon pump recall

March 24, 2023 By Sean Whooley

Datascope Getinge Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump

The FDA issued a notice determining a recall of Getinge subsidiary Datascope's Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company's Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in … [Read more...] about Getinge’s Datascope has another serious intra-aortic balloon pump recall

Filed Under: Balloons, Recalls, Regulatory Tagged With: Datascope, Getinge

Data backs splanchnic ablation procedure from Axon Therapies

March 22, 2023 By Sean Whooley

Axon Therapies Satera Ablation Catheter s

Axon Therapies today announced positive six-month results from a trial for its proprietary splanchnic ablation for volume management (SAVM) therapy. Dr. Marat Fudim, advanced heart failure specialist at Duke University Medical Center, presented results at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. The data came … [Read more...] about Data backs splanchnic ablation procedure from Axon Therapies

Filed Under: Catheters Tagged With: Axon Therapies

FDA sends warning letter to Olympus over endoscope manufacturing

March 17, 2023 By Sean Whooley

This images shows the Olympus logo.

The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility. This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year. According to the letter, the agency conducted an inspection of the Tokyo facility … [Read more...] about FDA sends warning letter to Olympus over endoscope manufacturing

Filed Under: Endoscopes, Recalls, Regulatory Tagged With: olympus

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