Becton Dickinson (NYSE:BDX) said this week it will spend $8 million to upgrade emissions controls at two medical device sterilization plants it operates in Georgia. The plants in Covington and Madison, Ga., both southeast of Atlanta, use ethylene oxide (EO) to sterilize medical devices. The federal Environmental Protection Agency recognizes EO as a carcinogen and lowered […]
Vyaire recall hits Medline’s Centurion Medical
Medline Industries recalled Centurion Medical’s primary warmer pack because it contains Vyaire Medical‘s recalled enFlow disposable cartridge that potentially exposes patients to unsafe aluminum levels. Nearly three million enFlow disposable cartridges were recalled in March. The product is designed to warm blood, blood products and intravenous solutions before IV administration, but the potential for aluminum […]
BD sues Stryker over PureWick catheter patents
Becton Dickinson (NYSE:BDX) this week levied a lawsuit against Stryker (NYSE:SYK), alleging infringement of patents covering its PureWick female external catheter. The lawsuit, filed August 12 in the U.S. District Court for Delaware, accused Stryker’s Sage Products subsidiary of violating two patents covering the PureWick device with Sage’s competing PrimaFit device, which Stryker acquired along with […]
BD beats Wall Street on Q3 earnings, reveals FDA denial of Lutonix PMA for PAD
This article has been updated to include information from the company’s earnings call with analysts. Becton Dickinson & Co. (NYSE:BDX) posted third-quarter results today that beat the consensus earnings forecast on Wall Street and maintained its FY2019 guidance, citing strong year-to-date results and continued momentum. On the downside, CEO Vincent Forlenza told analysts that the […]
BD updates infusion pump recalls
Becton Dickinson (NYSE:BDX) said today it has updated two voluntary recalls of certain Alaris infusion pump modules and infusion sets used with those modules. The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices. The Alaris model 8100 modules were manufactured between […]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, blood and […]
Sterigenics moves to upgrade shuttered device sterilization plant
Sterigenics said today that it has applied for permits to upgrade emissions controls at its Willowbrook, Ill. medical device sterilization plant, which had sterilized thousands of devices daily until its Feb.15 shutdown. The Illinois Environmental Protection Agency (EPA) closed the Willowbrook plant, citing excessive emissions of the sterilant ethylene oxide (EO), based on a federal […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
Zimmer Biomet taps medtech vet Upadhyay for CFO | Personnel Moves June 20 2019
Zimmer Biomet (NYSE:ZBH) said yesterday that longtime finance chief Daniel Florin is stepping down effective July 1, to be replaced as CFO by medical device veteran Suketu Upadhyay. Florin is slated to stay on in an advisory capacity “for a period following the succession,” Warsaw, Ind.-based Zimmer said. Upadhyay’s CV includes stints Bristol-Myers Squibb, Endo International, […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
BD sues NeuMoDx over patents for diagnostic device
Becton Dickinson (NYSE:BDX) and subsidiaries HandyLab and GeneOhm Sciences Canada have filed a lawsuit against diagnostics company NeuMoDx, claiming patent infringement. BD acquired small diagnostics company HandyLab (Ann Arbor, Mich.) in 2009 for $275 million. HandyLab was developing bench-top devices for fast and early detection of diseases, according to the complaint, filed in U.S. District […]
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