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 […]
Hospital Care
How the hospital may become a new market for CGMs
Following a breakthrough nod for Dexcom, CGMs may become a key part of hospital care. As the early stages of the COVID-19 pandemic required action in many forms, continuous glucose monitors became an unexpected part of hospital care. The FDA issued temporary guidance in April 2020 allowing for increased remote monitoring of hospital patients to […]
Dexcom wins FDA breakthrough nod for use of its CGM in hospitals
Dexcom (NSDQ:DXCM) announced that it received FDA breakthrough device designation for the use of its CGM in a hospital setting. The FDA early in the COVID-19 pandemic issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff. The guidance included continuous glucose monitors. “What started as a […]
Fort HealthCare, Ivenix partner on infusion safety effort with smart pump
Ivenix announced today that it successfully implemented its smart infusion pump at the Fort HealthCare hospital in Wisconsin. Boston-based Ivenix designed its Ivenix Infusion System, a combination of a large-volume infusion pump and infusion management software, to offer unique capabilities within the infusion therapy market, with pumps deployed at Fort HealthCare set to connect with […]
Roche launches its connected blood glucose meter in Europe
Roche announced today that it launched its Cobas Pulse system in select countries accepting CE mark approval in Europe. Basel, Switzerland–based Roche designed its Cobas Pulse system to combine the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities comparable to that of a smartphone. The platform joins Roche’s […]
Glytec partners with Roche to enhance insulin dosing decision support software
Glytec announced today that it entered into a strategic partnership with Roche Diagnostics USA for a digital health collaboration. Waltham, Massachusetts-based Glytec’s partnership combines its FDA-cleared Glucommander insulin dosing decision support software with Roche’s expertise in medical devices and IT solutions in an effort to address the challenges associated with inpatient blood sugar management at […]
ICU Medical’s Smiths Medical acquisition remains on track
ICU Medical (NASDAQ:ICUI) is a step closer to acquiring Smiths Medical after clearing a shareholders vote at Smiths’ British parent company, the Smiths Group. Almost all of the nearly 327 million Smiths Group shareholders voting on November 17 approved the $2.35 billion buy. Get the full story on our sister site Medical Tubing + Extrusion.
BD applies to start shipping Alaris pumps again
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 […]
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 […]
