Malfunctions Prompt Baxter Withdrawal Of Ambulatory Infusion Pump
This article was originally published in The Gray Sheet
Executive Summary
Baxter Healthcare will withdraw its only ambulatory infusion pump from the market over the next year and take a $45 mil. charge in the fourth quarter following several reports of device malfunction
You may also be interested in...
People In Brief
CoreValve gets reg affairs in order: Kalathi Thyagarajan, PhD, joins as VP-regulatory affairs & quality assurance. Thyagarajan, who has consulted for CoreValve since June, will be tasked with securing ISO certification of Irvine, Calif.-based CoreValve USA and managing the clinical trial for the ReValving percutaneous aortic valve system to support European regulatory approval. He is also responsible for interacting with FDA. Previously, Thyagarajan served in senior research and regulatory management roles at cardiac implant start-ups 3F Therapeutics and VenPro. He also worked at Edwards Lifesciences before its spin-off from Baxter in 2000. CoreValve recently said it may go public in 2007 (1"The Gray Sheet" Nov. 21, 2005, p. 17)...
People In Brief
CoreValve gets reg affairs in order: Kalathi Thyagarajan, PhD, joins as VP-regulatory affairs & quality assurance. Thyagarajan, who has consulted for CoreValve since June, will be tasked with securing ISO certification of Irvine, Calif.-based CoreValve USA and managing the clinical trial for the ReValving percutaneous aortic valve system to support European regulatory approval. He is also responsible for interacting with FDA. Previously, Thyagarajan served in senior research and regulatory management roles at cardiac implant start-ups 3F Therapeutics and VenPro. He also worked at Edwards Lifesciences before its spin-off from Baxter in 2000. CoreValve recently said it may go public in 2007 (1"The Gray Sheet" Nov. 21, 2005, p. 17)...
Baxter Stops Medication Management R&D Efforts To Focus On FDA Seizure
Baxter will halt all product development in its medication management division while it addresses design flaws with Colleague infusion pumps, seized by FDA Oct. 13