The U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been ...

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

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 ...

New York, USA, April 17, 2025 (GLOBE NEWSWIRE) -- Infusion Pumps Market to Soar at a CAGR ... particularly in the management of chronic diseases and critical care. Technological advancements ...

ICU Medical modified Minnesota-made infusion pumps without required FDA premarket review, leading to a warning that the devices are now considered adulterated and misbranded.

The infusion pumps market is experiencing significant growth due to the increasing demand for advanced healthcare solutions, particularly in the management of chronic diseases and critical care.

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).

On April 22, 2025, ICU disclosed receipt of a warning letter from the U.S. Food and Drug Administration ("FDA"), citing unauthorized changes to two of the Company's infusion pump products.

The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of ICU Medical, Inc. ("ICU Medical" or "the Company") (NASDAQ: ICUI ...

On April 22, 2025, ICU disclosed receipt of a warning letter from the U.S. Food and Drug Administration ("FDA"), citing unauthorized changes to two of the Company's infusion pump products. The FDA's ...

On April 22, 2025, the FDA published a warning letter issued to ICU Medical stating that the Company had “made multiple changes to the Medfusion Model 4000 Syringe Infusion Pump and CADD Solis ...