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FDA Seeks ‘Remanufacturing’ Feedback from Biomeds

A little more than a month ago, the FDA released the draft guidance “Remanufacturing of Medical Devices” and asked healthcare technology management professionals, original equipment manufacturers, third-party repair organizations and more to submit comments.

United Imaging Goes “All-in” for Nashville

United Imaging makes its debut at HealthTrust University and its in-person debut at AHRA in Nashville over the next two weeks. At both events, the company will focus on several unique aspects of how it solves pervasive pain points in procuring and owning medical imaging equipment.

TechNation Asks Biomeds to Share Right to Repair Issues

TechNation is proud to support and be an advocate for the Right to Repair movement in the healthcare technology management and health care community. A new web form specifically allows biomeds everywhere to report incidents when an original equipment manufacturer...

Delivering precision solutions for a changing world

Change has been the one constant in nuclear medicine from the beginning, with the steady arrival of new radiopharmaceuticals, new technologies and an evolving regulatory environment. Today, as nuclear medicine expands rapidly beyond diagnostics and into novel...

GE Healthcare Critical Care Suite 2.0

GE Healthcare Critical Care Suite 2.0

Research shows that up to 25 percent[1-5] of patients intubated outside of the operating room have misplaced endotracheal tubes (ETT) on chest X-rays, which can lead to severe complications for patients, including hyperinflation, pneumothorax, cardiac arrest and death. GE Healthcare’s Critical Care Suite 2.0[6] features a new AI algorithm to help clinicians assess ETT placements, a necessary and important step when ventilating critically ill patients. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile X-ray device for automated measurements, case prioritization and quality control that can help improve efficiency on the front lines.

1. Jemmett ME, Kendal KM, Fourre MW, Burton JH. Unrecognized misplacement of endotracheal tubes in a mixed urban to rural emergency medical services setting. Acad Emerg Med 2003;10:961–5.
2. Katz SH, Falk JL. Misplaced endotracheal tubes by paramedics in an urban emergency medical services system. Ann Emerg Med 2001;37:32–7.
3. Lotano R, Gerber D, Aseron C, Santarelli R, Pratter M. Utility of postintubation chest radiographs in the intensive care unit. Crit Care 2000;4:50–3.
4. McGillicuddy DC, Babineau MR, Fisher J, Ban K, Sanchez LD.
5. Is a postintubation chest radiograph necessary in the
emergency department? Int J Emerg Med 2009;2:247–9.
6. 510k pending at the FDA. Distributed in accordance with FDA imaging guidance regarding COVID-19 public health emergency.

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