B. Braun Medical said today it won FDA 510(k) clearance for its xevonta dialyzer and that it is launching the next-generation filter in the U.S. Get the full story at our sister site, Medical Design & Outsourcing.
B. Braun
B. Braun integrates Infusomat Space pump with Epic’s EMR system
B. Braun Medical said today it completed system integrations of its Infusomat Space Pump with Epic’s integrated EMR system. Get the rest of the story at our sister site, Medical Design & Outsourcing
B. Braun files IV cath patent infringement suit against Becton Dickinson
B. Braun Medical said today it, along with its subsidiaries filed a patent infringement lawsuit against Becton Dickinson & Co. (NYSE:BDX) over 10 U.S. patents related to IV catheter safety mechanisms. Bethlehem, Pa.- and Melsungen, Germany-based B. Braun said it is seeking an injunction and damages from Becton Dickinson for infringing on B. Braun’s patents through its […]
B. Braun pays nearly $8m to settle contaminated saline case
B. Braun Medical agreed to pay $7.8 million and agreed to the facts in a non-prosecution agreement to avoid criminal charges that it sold contaminated saline syringes. Bethlehem, Pa.- and Melsungen, Germany-based Braun bought the contaminated syringes from a company called Am2Pat, despite knowing beforehand of manufacturing problems at the North Carolina plant where the syringes were made, […]
B. Braun challenges ECRI Institute infusion pump ratings
B. Braun Medical today challenged infusion pump ratings out of the ECRI Institute after its Infusomat Space 2nd-generation large volume pump was given a 2-out-of-5 star rating. The Bethlehem, Penn.-based company said that the ECRI Institute has “lax protocol test methods for rating infusion pumps” and strongly disagreed with the evaluation of the Infusomat. The […]
FDA: B. Braun Dialog+ hemodialysis recall is Class I
B. Braun Medical is recalling its Dialog+ Hemodialysis systems due to an issue with defective conductivity sensors. The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences […]
B. Braun inks exclusive distro deal with NuMed for CP stent
B. Braun Interventional Systems said today it extended its exclusive U.S. distribution deal with NuMed for to include its newly-cleared Cheatham Platinum stent designed to treat native or recurrent coarctation of the aorta. The CP stent won FDA 510(k) clearance in March, and the commercial launch in the U.S. is scheduled to take place this week, […]
B. Braun, ICU Medical ink long-term distro deal
ICU Medical (NSDQ:ICUI) said today it inked a long-term distribution deal with B. Braun Medical for ICU’s SwabCap disinfecting cap for needlefree connectors for select countries outside the U.S. San Clemente, Calif.-based ICU Medical’s SwabCap is a disposable cap designed for disinfecting needlefree connectors with 70% isopropyl alcohol when attaching them to an intravenous catheter. “We look […]
B. Braun gets into managed care with First Databank
B. Braun Medical said yesterday it will offer clinical support and managed care resources for and infusion pump drug library through a collaboration with First Databank. Bethlehem, Penn.-based B. Braun said it will be the 1st implementation of an infusion pump drug library with FDB. “Our innovative drug library software furthers our commitment to reducing medication […]
US Senators urge FTC to probe Baxter, Braun & Hospira saline prices
Four U.S. Senators yesterday wrote the FTC urging a probe into possible illegal saline price inflation of 200-300% since a shortage of the fluid began in late 2013. The letter, sent to FTC chairwoman Edith Ramirez, was signed by Conn. dem senator Richard Blumenthal, Minn. dem Amy Klobuchar and Utah reps. Mike Lee and Orrin […]
B. Braun wins FDA nod for Infusomat pump
B. Braun Medical said today that it won 510(k) clearance from the FDA for its 2nd-generation, large-volume Infusomat pump for delivery of parenteral fluids, medications, blood and blood products. “Clinicians, including nurses and anesthesiologists, participated in extensive software navigation testing,” marketing, automation & infusion systems vice president Mike Golebiowski said in prepared remarks. “Based on their feedback, we optimized […]