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 […]
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, […]
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 […]
Ivenix wins 510(k) clearance for infusion system
Ivenix said today that its infusion system won 510(k) clearance from the FDA. The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix. The Boston-based company reported that infusion-related adverse drug events make up more than $2 million in healthcare costs […]
B. Braun pledges $1B to alleviate IV solution shortages
B. Braun said yesterday that it is investing $1 billion into new and enhanced IV therapy manufacturing facilities to help alleviate saline and other IV fluid shortages faced by healthcare providers in the U.S. The investment, dubbed the ‘Solutions for Life’ initiative, includes a new manufacturing facility in Daytona Beach, Fla. and improvements to existing […]
Medtronic touts new targeted drug delivery study results
Targeted drug delivery and conventional medical management have shown to have a reduction in healthcare use and costs for cancer patients in comparison to conventional medical management alone, according to a new study from Medtronic. The study found that there were significant cost savings to payers and fewer inpatient visits with shorter inpatient stays. It […]
Baxter cleared from DoJ antitrust saline probe
Baxter (NYSE:BAX) said yesterday that it has been cleared from a U.S. Dept. of Justice antitrust probe, launched in 2017, investigating companies that market intravenous saline solutions. The probe came as hospitals endured a shortage of intravenous saline solutions, which are used to hydrate hospital patients. The shortage dates back to late 2013, after drugmakers told […]
ivWatch inks development, commercialization deal with ICU Medical
ivWatch said today that it inked a long-term development and commercialization deal to integrate its continuous IV monitor into new medical devices and systems made by ICU Medical (NSDQ:ICUI). The deal paves the way for EHR interoperability, according to ivWatch, by connecting the two companies’ systems and enabling the exchange of data. “Our two companies can […]
Smiths Medical spikes merger talks with ICU Medical
Smiths Group (LON:SMIN) said yesterday that it’s spiking merger talks with ICU Medical (NSDQ:ICUI) after rejecting a nearly $4 billion offer earlier this month. The British company and San Clemente, Calif.-based ICU revealed negotiations in May about a possible union with Smiths Medical. Smiths, said to be eyeing the exit door last month, reportedly rejected a cash-and-stock offer […]
ivWatch wins CE Mark for continuous IV site monitor
ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device. The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through group purchasing contracts with Premier and Vizient. ivWatch also touted that it obtained ISO 13485:2016 certification through the Medical Device Single Audit Program. “Peripheral IV […]
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