Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

Syringe pumps or inline piston pumps are typically ... Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing ...

Belgium’s largest drugmaker UCB (Euronext: UCB) today revealed that it has received approval from Japan’s Pharmaceuticals and ...

New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform. Unlike traditional pumps that rely on specific setups and conditions for accurate delivery ...

The Food and Drug Administration sent a warning letter in early April to ICU Medical, alleging the company failed to submit premarket notifications for changes to infusion pumps. FDA inspectors ...

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important regulatory checks after a recent recall, according to a Food and Drug ...

ICU Medical also received 510(k) clearance for updated versions of the Plum Duo precision IV pump and LifeShield infusion safety software, completing the initial launch of the ICU Medical IV ...

Infusion pumps are commonly used in hospitals to deliver fluids to patients during surgery. However, many of the current ...

NEW YORK, NY - May 1, 2025 ( NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against ICU Medical, Inc. (“ICU Medical” or the “Company”) (NASDAQ: ICUI).