Automation in PCLC devices is enabled by the control system technology in host medical devices such as infusion pumps, ventilators, extracorporeal systems (e.g., dialysis delivery systems and...

Jan 14, 2025 · In this article, you will learn what closed-loop systems are, where they are used in medicine, and what regulatory requirements they need to meet. The article also reveals how …

Et Control requires the use of specific CARESCAPE Respiratory Gas Modules, E-sCAiOE or E-sCAiOVE, which were previously cleared under K211171. The “E” designation at the end of …

For the current test system, the use of a negative control polytetrafluoroethylene (PTFE) and a positive control (latex) are necessary to demonstrate the validity and sensitivity of the test. The...

By the end of 2020, the U.S. Food and Drug Administration received Tidepool’s application for an interoperable automated glycemic controller based on Loop. After 2 years, the FDA approved …

Food and beverage and pharmaceutical companies have several processes that require validation due to FDA and other international safety laws. When some measurements need to be shared …

Jun 2, 2021 · To satisfy this compliance need, companies will need to connect related processes within their quality system to close the loop between related pre- and post-market activities …

This guidance document provides the FDA’s recommendations on design considerations, non-clinical testing, animal studies, and labeling to support premarket submissions for medical …

Jan 24, 2023 · Most importantly, it means that once a third-party interoperable ACE pump is cleared by the FDA, we can put a version of Tidepool Loop in the App Store that works with …

Dec 23, 2024 · This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP …