Category: Cook MedicalSyndicate content

FDA meeting over uterine surgical device and cancer risk sparks debate | Regulatory news for the week of July 14, 2014

July 15, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Debate heats up during FDA meeting over uterine surgical device and cancer risk; Merit Medical wins China OK for Aero device; Back in the USA: Cook Medical's Evolution lead extraction device returns; FDA flags Zynex Medical over chronic pain devices; FDA offers new guidance on 510(k) risk/benefit review

Debate heats up during FDA meeting over uterine surgical device and cancer risk

July 11, 2014 by Ingrid Mezo

Back in the USA: Cook Medical's Evolution lead extraction device returns

July 10, 2014 by Brad Perriello

Cook Medical says its Evolution cardiac lead extraction device line is back on the U.S. market after a 2-month hiatus prompted by an FDA warning.

Back in the USA: Cook Medical's Evolution lead extraction device returns

Cook Medical said today that it's Evolution RL and Evolution Shortie RL cardiac lead extraction devices are back on the U.S. market after a 2-month suspension prompted by an FDA warning issued last April.

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GOPers want answers on draft guidances | Medtech regulatory news for the week of May 12, 2014

May 13, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Senate Republicans want answers from FDA commish Hamburg on draft guidances; Medtech regulation: FDA releases April 2014 510(k) decisions; Prosthetic arm that translates muscle signals into action wins FDA approval; FDA warns Cook Medical on unapproved changes to Evolution lead extractor; FDA: Foreign medtech firms receive excess manufacturing violations.

Senate Republicans want answers from FDA commish Hamburg on draft guidances

May 8, 2014 by Brad Perriello

Senate Republicans want answers from FDA commish Hamburg on draft guidances

FDA warns Cook Medical on unapproved changes to Evolution lead extractor

May 7, 2014 by Brad Perriello

The FDA sends a warning letter to Cook Medical, accusing the company of making unapproved changes to its Evolution RL lead extraction device.

FDA warns Cook Medical on unapproved changes to Evolution lead extractor

The FDA last month accused Cook Medical of selling an unapproved device in the U.S., saying changes made to Cook Vascular's Evolution RL cardiac lead extraction device require the medical device company to file a new clearance application with the watchdog agency.

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Philly court sets up new pelvic mesh mass tort

February 20, 2014 by Brad Perriello

The Philadelphia Court of Common Pleas establishes a mass tort for all pelvic mesh lawsuits filed in its jurisdiction.

Philly court sets up new pelvic mesh mass tort

A Pennsylvania state judge ordered the creation of a mass tort this week to collect product liability lawsuits filed over pelvic mesh products against some of the largest names in medical devices.

Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas, ordered Feb. 11 that "all currently filed pelvic mesh matters shall be transferred to the Complex Litigation Center Pelvic Mesh Mass Tort Program" for coordination, according to court documents.

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Bard mesh cases slated for discovery

January 27, 2014 by Brad Perriello

A federal judge orders the selection of 200 lawsuits for discovery proceedings in the multi-district litigation over C.R. Bard's Avaulta pelvic mesh products.

Bard mesh cases slated for discovery

The mass tort against C.R. Bard (NYSE:BCR) is about to generate an avalanche of paper after a federal judge ordered the plaintiffs and Bard to choose some 200 lawsuits for discovery.

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Cook Medical begins esophageal stent study

December 12, 2013 by Chris Walker

Cook Medical begins a clinical trial of its Evolution esophageal stent.

Cook Medical starts clinical study for esophageal stent

Cook Medical said it started a multi-center clinical trial of its Evolution esophageal stent.

The study is designed to test the possibility of removing the self-expanding, covered metal stent after treatment of malignant and benign strictures including strictures, fistulas or perforations.

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