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Vascular

FDA warns Cook Medical on 'nonconformance' issues

October 28, 2014 by Brad Perriello

The FDA sends a warning letter to Cook Medical, saying inspections last summer turned up problems at a Bloomington, Ind., plant that makes vascular devices.

FDA warns Cook Medical on 'nonconformance' issues

The FDA today released a warning letter it sent to Cook Medical last month, flagging problems found during inspections of a Bloomington, Ind., plant last summer.

AngioDynamics revises results, ups guidance

October 10, 2014 by Alexander Soule

AngioDynamics revises its financial results back to the beginning of its 2012 fiscal year, saying it's still assessing its internal controls while getting improved visibility from a new ERP platform.

AngioDynamics restates results, ups guidance

DePuy's Codman Neuro expands in Asia Pacific with new approvals

September 8, 2014 by Arezu Sarvestani

Codman Neuro prepares to widen its Asia Pacific footprint with regulatory approvals in China, South Korea and Taiwan for its Revive SE thrombectomy system.

DePuy's Codman Neuro touts Asia Pacific approvals for thrombectomy device

Massachusetts-based Codman Neuro is preparing to take Asia Pacific by storm with new regulatory wins in China, South Korea and Taiwan for the company's Revive SE thrombectomy device.

Cook's recall gets FDA's highest-risk label

September 5, 2014 by Arezu Sarvestani

The FDA slaps its highest-risk Class I label on Cook Medical's recall of CloverSnare vascular retrieval snares.

Cook's recall gets FDA's highest-risk label

The FDA issued a warning this month on Cook Medical's medical device recall, warning that a defect in certain of the company's CloverSnare 4-Loop Vascular Retrieval Snares could harm patients.

Federal device regulators gave the recall Class I status, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

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Study: St. Jude's FFR helps boost stenting over drug therapy alone

September 2, 2014 by Arezu Sarvestani

Researchers report that St. Jude Medical's fractional flow reserve technology helps slash adverse events, especially urgent revascularizations, compared with medical therapy alone.

Study: St. Jude's FFR tech helps cut adverse events in half

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