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, […]
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 […]
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 […]
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]
DHS warns again on cybersecurity flaw in BD’s Alaris infusion pump
The U.S. Homeland Security Dept. yesterday warned of two more cybersecurity vulnerabilities with the Alaris infusion pump made by Becton, Dickinson (NYSE:BDX). The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses unearthed by researchers at CyberMDX, said the vulnerabilities could allow a malicious attacker to completely disable BD’s Alaris Gateway Workstation and install malware […]
Becton Dickinson cuts earnings outlook on paclitaxel warning
Becton Dickinson & Co. (NYSE:BDX) missed the consensus sales forecast for its fiscal second quarter and cut its outlook for the rest of the year, sending its share price down today on Wall Street. The cut to its earnings guidance is due to “recent regulatory and market pressures related to paclitaxel-coated devices,” Franklin Lakes, N.J.-based BD […]
BD launches second-gen ergonomic injection pen
Becton Dickinson & Co. (NYSE:BDX) said this week that its second-generation BD Nano pen needle won 510(k) clearance from the FDA. The company’s needles are designed to provide a more reliable subcutaneous injection depth, according to BD. Using a contoured needle base and distributed pressure, the pen needle lessens the risk resulting from user injection force […]
FDA releases BD lock flush syringe facility warning letter
The FDA this week released a warning letter it sent to Becton Dickinson (NYSE: BDX) last month over issues it found at the company’s Franklin, Wisc.-based facilities, which produces pre-filled Heparin and 0.9% sodium chloride lock flush syringes. The warning letter came from an inspection of the facilities which took place between May 16, 2018 and August […]
BD inks UAE insulin pen distro deal with Julphar
Pharmaceutical manufacturer Julphar said yesterday it inked a deal with BD (NYSE: BDX) to supply disposable insulin pens to the United Arab Emirates. Through the deal, individuals will be able to purchase BD’s Vystra disposable pens featuring Julphar’s human insulin formulations, including its Jusline R, Jusline N and Jusline 30/70. The same system is slated to be […]
DHS warns on BD’s Alaris pump
The U.S. Dept. of Homeland Security issued an advisory this week, warning consumers that BD’s (NYSE: BDX) Alaris syringe pumps can be hacked via a vulnerability that gives a remote attacker unauthorized access to the device when it is connected to a terminal server. BD determined that the affected products are not sold within the U.S., a […]
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