Baxter (NYSE:BAX) this week touted FDA clearance for its next-generation Sigma Spectrum infusion pump with safety software that allows hospitals to set drug delivery parameters to minimize dosing errors.
The new model comes with upgrades to the safety-oriented "Master Drug Library" as well as asset-tracking features that help hospitals manage its Sigma Spectrum inventory. Baxter plans to begin commercial launch this summer to a selected group of healthcare facilities, according to a company statement.
"Clinicians are looking for integrated systems that are efficient and cost effective, and allow hospital staff to focus on providing quality care for patients," Baxter hospital products business president Brik Eyre said in prepared remarks. "We are excited to bring the next generation of Baxter’s Sigma Spectrum Infusion Pump with Master Drug Library and its advanced, patient-centered safety technology to the U.S. marketplace."
The Sigma suite of pumps have been on the market for a while and have for 3 years in a row won the "Best in KLAS" award from the healthcare technology rating firm KLAS.
The FDA win is good news for Baxter, which has had some recent recall news for its infusion pumps. Earlier this month the FDA assigned their highest-risk Class I label after Baxter recalled a series of Sigma Spectrum Infusion Pumps over a software issue that had been associated with 9 "severe adverse events" and more than 3,500 reported failures.
Earlier this year the FDA warned Baxter about infractions at an Illinois plant where Baxter makes its HomeChoice dialysis device and at a California plant that makes drug infusion pumps. Baxter replaced failed components that didn’t meet specs, but never investigated the cause of the failures in the HomeChoice peritoneal dialysis systems, according to the FDA. It was the 2nd time the FDA flagged Baxter for the infraction, 1st noted during inspections in the spring and summer of 2012, the agency said.
BAX shares closed last night at $75.37, up 8.4% since the start of the year.