BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance for its recall-plagued Alaris infusion pump system. BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March […]
Hospital Care
Glytec launches new insulin management system
Glytec announced today that it introduced the latest version of its eGlycemic Management System (eGMS) for managing insulin. Waltham, Mass.-based Glytec’s eGMS is centered around the FDA-cleared Glucommander algorithm, which leverages real-time and historical data to recommend insulin dosing by learning each patient’s insulin sensitivity and anticipating future needs, leading to a personalized treatment regime […]
FDA produces list of ‘essential’ devices, drugs for health, military emergencies
The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that the Trump administration ordered the agency to buy domestically to fight the novel coronavirus and future health and military crises. Devices on the list include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, devices […]
Fauci: Hundreds of millions of COVID-19 vaccine doses could be ready in January
Dr. Anthony Fauci said this morning that hundreds of millions of doses of a vaccine for COVID-19 could be ready by January. In an interview on the Today Show, the director of the National Institute of Allergy and Infectious Diseases said that a vaccine candidate is in the first phase of a clinical trial. If the second […]
Qosina touts single-use bioprocessing components for coronavirus response
With the bioprocess industry mobilizing to support the development of tests, vaccines and treatments for COVID-19, medtech distributor Qosina said that its supply of single-use bioprocessing components can offer significantly reduced time to clinic and market over multi-use systems during situations like the coronavirus pandemic. Ronkokoma, N.Y.-based Qosina said it also provides 3D CAD models and […]
Whistleblowers accuse Fla. VA hospital of ignoring Alaris recall
Staff members at a Florida U.S. Veterans Affairs Dept. hospital reportedly said leadership ignored the recall of the Alaris infusion pump made by Becton Dickinson (NYSE:BDX). Leaders at the James Haley Veterans’ Hospital in Tampa dismissed repeated warnings about BD’s device over multiple weeks, even after a patient’s life was endangered, the Military Times reported. […]
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 […]
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 […]
