ICU Medical, Inc. ICUI, yesterday, announced the FDA’s 510(k) clearance for the Plum Solo precision IV pump, a single-channel complement to the dual-channel Plum Duo. The company also received the 510 ...

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

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important ...

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).

According to the government agency, the Company "made multiple changes to the Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump that could significantly affect ...

The global healthcare industry continues to evolve at an extraordinary pace, driven by advancements in medical technology and the ever-growing demand for personalized treatment solutions. Among the ...

Epoprostenol sodium is delivered by continuous i.v. administration using an ambulatory infusion pump through an indwelling, surgically implanted central line. Treprostinil sodium, which has a ...

FDA inspectors found ICU Medical made multiple changes to the Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump that could significantly affect the devices ...

the Medfusion Model 4000 Syringe and the CADD Solis VIP Ambulatory infusion pump. But the company failed to submit a premarket submission to the agency for “significant changes or modifications ...