New Products In Brief

Enhanced version of Hospira Inc.’s general drug infusion pump will roll out to current customers this quarter, with shipments to previously contracted customers in the second quarter, according to the company. Hospira announced receipt of 510(k) clearance March 8. Symbiq 3.13 is one of the first general infusion systems to gain clearance under FDA’s April 2010 draft infusion pump guidelines, Hospira noted. Described by the Lake Forest, Ill.-based firm as “a technologically advanced infusion device with clinician-friendly features designed to help improve workflow and decrease medication errors,” Symbiq’s platform enhancements include wireless connectivity to facilitate I.V. integration, improved software reliability and updated software design. The original version of Symbiq was 510(k)-cleared in 2006. Asante’s Pearl was the first fully-programmable insulin pump cleared under the 2010 infusion pump guidelines, which recommend that manufacturers include special safety arguments, or “assurance cases,” in their 510(k) submissions. (See Also see "New Products In Brief" - Medtech Insight, 6 June, 2011..)

Firm gains 510(k) clearance for its Ventana Companion Algorithm Progesterone Receptor (PR) (1E2) image analysis application for use in conjunction with the firm’s Virtuoso software and iScan Coreo Au scanner,...