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MINNEAPOLIS - Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company with annual revenue of $8.32 million, has received U.S. Food and Drug Administration 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC), the company announced Thursday. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 2.16.
The medical technology firm, which specializes in fluid management, has added a 15 cm insertable length option to its existing 11 cm catheter. Both catheters are coil-reinforced, 6F devices designed to provide peripheral venous access for ultrafiltration therapy. InvestingPro analysis shows the company holds more cash than debt on its balance sheet, potentially supporting its product development initiatives.
The dELC is indicated for use up to 72 hours to attain venous access with the company’s Aquadex FlexFlow and Aquadex SmartFlow systems for ultrafiltration therapy.
"Clinicians have asked for dependable peripheral access that works across inpatient units and emerging outpatient programs," said John Erb, Chief Executive Officer of Nuwellis. "With two extended lengths and coil reinforcement, the dELC helps teams match access to the patient and care setting."
According to the company, the catheter’s coil reinforcement and dual-lumen design enable consistent blood flow for ultrafiltration therapy, while the choice of lengths helps match patient size and site-of-care needs.
The clearance supports Nuwellis’ multi-year plan to build a comprehensive fluid management platform for hospitals and clinics to standardize patient identification and ultrafiltration therapy across various care settings.
The company’s Aquadex SmartFlow system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics.
The information in this article is based on a press release statement from Nuwellis. For comprehensive financial analysis and 15 additional ProTips about Nuwellis, including detailed valuation metrics and growth prospects, visit InvestingPro, where you’ll find expert insights and in-depth research reports.
In other recent news, Nuwellis Inc. reported a challenging second quarter of 2025, experiencing a 21% decline in year-over-year revenue, totaling CAD $1.7 million. The company also faced a significant net loss during this period. Despite these setbacks, Nuwellis is pursuing strategic initiatives to improve its financial situation and expand its market presence. Additionally, the company announced it has entered into a non-binding letter of intent to acquire Rendiatech, Ltd., an Israeli-based medical device company. This proposed acquisition aims to enhance Nuwellis’s existing technology platform by integrating Rendiatech’s real-time urine flow and acute kidney injury monitoring technologies. Rendiatech’s Clarity RMS, an FDA-cleared critical care monitoring system, and its upcoming Clarity Prime system are expected to advance Nuwellis’s capabilities in fluid management. These developments reflect Nuwellis’s efforts to broaden its technological offerings and address ongoing financial challenges.
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