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Hospital Care

BD applies to start shipping Alaris pumps again

April 26, 2021 By Nancy Crotti

BD Alaris infusion pump

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 […]

Filed Under: Drug-Device Combinations, Featured, Hospital Care, Regulatory/Compliance Tagged With: BD, FDA

Glytec launches new insulin management system

March 30, 2021 By Sean Whooley

Glytec

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Hospital Care, Patient Monitoring Tagged With: Glytec

FDA produces list of ‘essential’ devices, drugs for health, military emergencies

November 2, 2020 By Nancy Crotti

FDA-logo-new

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 […]

Filed Under: Cardiovascular, Drug-Device Combinations, Hospital Care, Patient Monitoring, Pharmaceuticals, Respiratory Tagged With: Donald Trump, FDA

Fauci: Hundreds of millions of COVID-19 vaccine doses could be ready in January

April 30, 2020 By Nancy Crotti

coronavirus COVID-19

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 […]

Filed Under: Business/Financial News, Clinical Trials, Hospital Care Tagged With: coronavirus, COVID-19, Gilead Sciences, National Institutes of Health

Qosina touts single-use bioprocessing components for coronavirus response

April 8, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Hospital Care Tagged With: coronavirus, COVID-19, Qosina

Whistleblowers accuse Fla. VA hospital of ignoring Alaris recall

August 27, 2019 By Sean Whooley

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. […]

Filed Under: Featured, Hospital Care, Recalls Tagged With: Becton Dickinson

BD updates infusion pump recalls

July 18, 2019 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Recalls, Regulatory/Compliance Tagged With: Becton Dickinson, FDA

BD recalls SmartSite syringe administration set

July 2, 2019 By Brad Perriello

Becton Dickinson

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, […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Hospital Care, Pediatrics, Recalls, Regulatory/Compliance Tagged With: Becton Dickinson

DHS warns again on cybersecurity flaw in BD’s Alaris infusion pump

June 14, 2019 By Danielle Kirsh

This is the logo of BD.

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 […]

Filed Under: Hospital Care, Regulatory/Compliance Tagged With: BD, Becton Dickinson

Ivenix wins 510(k) clearance for infusion system

June 11, 2019 By Sarah Faulkner

Ivenix logo

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Hospital Care, Pharmaceuticals, Regulatory/Compliance Tagged With: Ivenix

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