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Danielle Kirsh

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

Fresenius Kabi has a Class I recall of Ivenix Infusion System software

April 18, 2024 By Danielle Kirsh

Fresenius Kabi Ivenix infusion system

The FDA this week labeled Fresenius Kabi’s recall of some Ivenix Infusion Systems (IIS) as Class I, the most serious kind. Fresenius Kabi USA issued the recall of Ivenix Infusion System LVP software, its infusion pump software, due to an issue of multiple software anomalies occurring that can potentially result in serious patient harm or […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Technology Tagged With: FDA, Fresenius Kabi

FDA approves Medinol drug-eluting coronary stent

October 24, 2023 By Danielle Kirsh

Medinol-Elunir-Perl

Medinol this week announced it received FDA approval for its Elunir-Perl drug-eluting stent (DES) for the treatment of coronary artery disease. Elunir-Perl is the latest evolution in the company’s Elunir DES product portfolio. It has four radiopaque markers, two at each end of the stent, as well as a hybrid polymer-metal radiopaque catheter tip. The […]

Filed Under: Drug-Device Combinations, Stents Tagged With: medinol

B. Braun launches DoseTrac Enterprise infusion management software

June 1, 2023 By Danielle Kirsh

bbraun logo

B. Braun today announced it launched its next generation of infusion management software, called DoseTrac Enterprise. The new software allows organizations to receive a mix of real-time views and retrospective reporting features better to understand their infusion pump fleet and associated data. DoseTrac Enterprise can connect up to 40,000 pumps at an unlimited number of […]

Filed Under: Drug-Device Combinations Tagged With: B. Braun

Fresenius Kabi recall of Ivenix infusion systems in Class I

April 19, 2023 By Danielle Kirsh

Fresenius Kabi logo updated

The FDA this week said the Fresenius Kabi recall of some Ivenix infusion systems is Class I, the most serious kind. Fresenius Kabi is recalling some Ivenix infusion systems due to a leak in the system that allows fluid to enter the administration set loading area near the air detector. The leak could damage the electrical system […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: Fresenius Kabi

Fresenius Kabi wins Vizient contract for Ivenix infusion system

April 18, 2023 By Danielle Kirsh

Fresenius Kabi Ivenix

Fresenius Kabi this week announced its Ivenix infusion system was awarded an Innovative Technology contract from Vizient. Vizient members include more than half of all acute care hospitals in the U.S., and the Innovative Technology contracts are recommended after review and interaction with products submitted through the organization’s program. The contract sets terms for hospitals […]

Filed Under: Business/Financial News, Hospital Care Tagged With: Fresenius Kabi

Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.

January 19, 2023 By Danielle Kirsh

SurModics

The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable. According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to […]

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Surmodics

Ascensia Diabetes integrates its Eversense CGM with Apple Health

November 7, 2022 By Danielle Kirsh

Marketing image Senseonics Eversense E3 Ascensia Diabetes Care

  Ascensia Diabetes Care announced today that it has updated its Eversense Continuous Glucose Monitoring system app to integrate with Apple Health. The Parsippany, N.J.-based company makes the Contour Blood Glucose Monitoring (BGM) system and distributes Senseonics’ Eversense CGM system. The new Apple Health integration will allow people with diabetes using Senseonics’ Eversense CGM systems to […]

Filed Under: Diabetes, Featured, mHealth (Mobile Health) Tagged With: Ascensia Diabetes Care, Senseonics

Medtronic launches Onyx Frontier drug-eluting stent

August 25, 2022 By Danielle Kirsh

Onyx Frontier Medtronic

Medtronic (NYSE:MDT) launched its newest drug-eluting coronary stent, Onyx Frontier. The Fridley, Minnesota-based company designed the Onyx Frontier drug-eluting stent (DES) to build upon its Resolute Onyx DES. It uses the same stent platform as the Resolute Onyx and has an enhanced delivery system to increase acute performance in interventional coronary artery disease procedures. Get […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Stents, Vascular Tagged With: Medtronic

Retractable Technologies downsizes workforce

June 8, 2022 By Danielle Kirsh

Retractable Technologies

Retractable Technologies this week announced that it has reduced its workforce by 16% due to the completion of its facility expansion efforts — and the completion of U.S. government orders related to COVID-19 vaccines. The staff reduction will affect the Little Elm, Texas-based company’s production, operations and logistics departments. Retractable Technologies said in an SEC filing that there […]

Filed Under: Pharmaceuticals Tagged With: Retractable Technologies

FDA approves GE Healthcare software that automates anesthesia, reduces greenhouse gas emissions during surgery

April 19, 2022 By Danielle Kirsh

GE Healthcare

GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control software for general anesthesia delivery. The software is cleared for use with GE Healthcare’s Aisys CS2 anesthesia delivery system. The Chicago-based company initially released the technology in Europe in 2010 and is currently used in over 100 countries. Get the full […]

Filed Under: Hospital Care Tagged With: GE Healthcare

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