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.
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 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.
Innovative AAA device offers new, less invasive option for patients and physicians.
Codman Neuro expands global footprint in Asia Pacific.
Codman Neuro prepares to widen its Asia Pacific footprint with regulatory approvals in China, South Korea and Taiwan for its Revive SE thrombectomy system.
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.
The FDA slaps its highest-risk Class I label on Cook Medical's recall of CloverSnare vascular retrieval snares.
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."
Researchers report that St. Jude Medical's fractional flow reserve technology helps slash adverse events, especially urgent revascularizations, compared with medical therapy alone.