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Nuwellis, Inc. (NASDAQ:NUWE), a medical device company with a market capitalization of $2.93 million, announced Thursday that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). The announcement was made in a statement based on a press release and disclosed in a filing with the Securities and Exchange Commission.
The company, headquartered in Eden Prairie, Minnesota, stated that the FDA clearance applies to a new size of its dELC product. No additional details regarding the size specifications or expected commercial availability were provided in the filing. According to InvestingPro data, Nuwellis maintains a healthy gross profit margin of 62.35% and holds more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn.
Nuwellis develops medical devices categorized under electromedical and electrotherapeutic apparatus. The company’s common stock is listed on the Nasdaq Capital Market under the symbol NUWE.
The information is based on a press release statement included in Nuwellis’s SEC filing.
In other recent news, Nuwellis, Inc. reported a challenging second quarter of 2025, marked by a 21% decline in revenue compared to the previous year, with total revenue reported at CAD $1.7 million. The company also faced a significant net loss during this period. In an effort to expand its market presence and improve financial standing, Nuwellis announced a non-binding letter of intent to acquire Rendiatech, an Israeli company specializing in real-time urine flow and acute kidney injury monitoring technologies. This proposed acquisition aims to enhance Nuwellis’s technology platform with Rendiatech’s Clarity RMS, an FDA-cleared critical care monitoring system. Additionally, Nuwellis received FDA clearance for a new size of its Dual Lumen Extended Length Catheter, adding a 15 cm insertable length option to its existing product line. These recent developments reflect Nuwellis’s strategic focus on broadening its technology offerings and addressing operational challenges.
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