Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning from the FDA regarding unauthorized changes to its infusion pump products [1][2]. Group 1: FDA Warning and Product Issues - On April 22, 2025, ICU disclosed that it received a warning letter from the FDA, which cited unauthorized modifications to two of its infusion pump products [2]. - The FDA's letter described the pumps as "adulterated" and "misbranded," indicating that the changes could significantly affect the functionality of the devices, particularly their delivery profile and alarm functionality [2]. - Concerns were raised about the safety and efficacy of the devices due to these modifications, questioning the adequacy of ICU's regulatory disclosures [2]. Group 2: Stock Market Reaction - Following the FDA warning, ICU's stock price dropped by $6.04 per share, or 4.42%, closing at $130.68 per share on April 22, 2025 [3]. Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of ICU investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. ICU Medical is the subject of an FDA warning letter published on April 22, 2025. 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 safety or effectiveness of these devices." The FDA states that the Company's ...

Core Points - ICU Medical, Inc. will release its first quarter 2025 earnings results on May 8, 2025, at approximately 4:00 p.m. ET [2] - A conference call to discuss the results will take place on the same day at 4:30 p.m. ET [2] - The conference call can be accessed via phone and will also be available through a webcast on the company's website [2] Company Overview - ICU Medical is a global leader in infusion systems, infusion consumables, and high-value critical care products [3] - The company focuses on providing quality, innovation, and value to clinical customers worldwide [3] - ICU Medical is headquartered in San Clemente, California [3]

ICU Medical (ICUI) announced at the 24th Annual Needham Virtual Healthcare Conference that it has developed a proactive strategy to mitigate the potential financial ramifications of the newly imposed tariffs announced by the Trump Administration. These tariffs, part of a broader trade policy shift, have already led to a notable decline in MedTech stocks and introduced uncertainty within the medical device industry. Despite these challenges, ICU Medical remains cautiously optimistic about its position, under ...

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(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 Performance Platform.The Plum Solo expands the capabilities of the IV Performance Platform by offering a single-channel pump designed to work along ...

New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform. SAN CLEMENTE, Calif., April 7, 2025 /PRNewswire/ -- ICU Medical Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Solo™ precision IV pump, a single-channel complement to the dual-channel Plum Duo™. ICU Medical also received 510(k) clearance for ...

SAN CLEMENTE, Calif., March 24, 2025 (GLOBE NEWSWIRE) -- ICU Medical (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced that Company management will present at the 24th Annual Needham Virtual Healthcare Conference being held April 7-10, 2025. ICU Medical’s presentation will be on Monday, April 7, 2025 at 8:00 a.m. PT (11:00 a.m. ET). Company management will also be participating in one-on-one meetings on Monday, April 7, 2025. The presentation wi ...

Group 1 - ICU Medical will participate in a fireside chat at the KeyBanc Healthcare Forum on March 19, 2025, at 8:15 a.m. PT (11:15 a.m. ET) [1] - The fireside chat will be available for live webcast and replay on the company's website [2] - ICU Medical is a global leader in infusion systems and critical care products, focusing on quality, innovation, and value for clinical customers [3]

Financial Data and Key Metrics Changes - Revenue for Q4 was $622 million, representing a total company growth of 9% on a constant currency basis or 8% reported, aided by a temporary shortage in IV Solutions [9][10] - Adjusted EBITDA was $106 million, an increase of 22% compared to $86 million last year [27] - Adjusted diluted earnings per share (EPS) for the quarter was $2.11, compared to $1.57 last year [25] Business Segment Data and Key Metrics Changes - Consumables business grew 6% both in constant currency and reported terms in Q4 [11] - IV Systems business grew 7% reported and 4% constant currency, marking the best absolute quarter in pumps [12] - Vital Care segment grew 16% on a constant currency and reported basis, primarily due to the national shortage in IV Solutions [13] Market Data and Key Metrics Changes - The broader demand and utilization environment in Q4 remained solid across almost every geography [10] - The capital environment is stable, with necessary investments being completed [10] Company Strategy and Development Direction - The company is preparing for a joint venture with Otsuka Pharmaceutical Factory, which is expected to enhance operational capabilities and customer service [14] - Focus on improving profitability through operational efficiencies and innovation in product offerings [44][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving healthy revenue growth in all differentiated product lines and addressing under-earning issues [16][49] - The company aims to improve free cash flow and profitability by completing quality remediation and integration activities [40][53] Other Important Information - The company expects the IV Solutions JV transaction to close in the second quarter of 2025, impacting financial reporting [29][30] - Anticipated reduction in adjusted revenue of $350 million and adjusted EBITDA of $25 million post-JV transaction [31] Q&A Session Summary Question: What is driving the growth in Consumables? - Management indicated that growth was driven by a combination of new installs, global growth, and pricing [60] Question: What was the EBITDA margin excluding IV Solutions in 2024? - Management did not disclose specific figures but suggested using reported revenue and EBITDA for estimates [62] Question: What is the demand environment for capital equipment? - Management noted that capital outlays are being made, and transactions are moving forward [80] Question: Can you elaborate on the balance sheet and leverage after the JV? - Management stated a comfortable leverage ratio around 2 times is targeted, with expected deleveraging from the JV transaction [92] Question: What are the drivers for achieving the $500 million EBITDA goal? - Management highlighted sustained revenue growth, gross margin improvements, and currency stabilization as key drivers [128]

ICU Medical, Inc. (NASDAQ:ICUI) Q4 2024 Earnings Conference Call February 27, 2025 4:30 PM ET Company Participants John Mills - ICR, IR Vivek Jain - Chairman and CEO Brian Bonnell - Chief Financial Officer Conference Call Participants Jayson Bedford - Raymond James Brett Fishbin - KeyBanc Capital Markets Charlie Strauzer - CJS Securities Michael Toomey - Jefferies Joseph Conway - Needham Operator Good day. And welcome to the ICU Medical, Inc. Fourth Quarter 2024 Earnings Conference Call. All participants wi ...