SkyDance Vascular Gains FDA Clearance for Innovative Osprey Midline Closed IV Catheter System

New Extended Dwell Catheter System Poised to Advance PIVC Patient Safety and Outcomes

DELRAY BEACH, FL, UNITED STATES, May 6, 2025 /EINPresswire.com/ -- SkyDance Vascular, Inc. (SkyDance) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its novel Osprey Midline Closed IV Catheter System (Extended Dwell Catheter). This latest development builds upon the success of SkyDance’s previously cleared OspreyF20 and OspreyV2-F20 catheters, marking a significant step forward in midline catheter technology and underscoring the company’s ongoing commitment to enhancing patient safety and improving clinical outcomes in peripheral intravenous catheter (PIVC) procedures.

The Osprey Midline Closed IV Catheter System is engineered to overcome key limitations associated with existing integrated midline catheters. Utilizing proprietary through-the-needle technology, the system is designed to improve insertion success rates, extend the duration of catheter placement (dwell times), and decrease the occurrence of complications. This innovation empowers clinicians with greater control and enhanced reliability during vascular access procedures.

“The FDA clearance of the Osprey Midline Closed IV Catheter System represents a transformative advancement in the midline catheter landscape,” stated Bill Bold, CEO of SkyDance Vascular. “Our OspreyIV platform is specifically designed to establish a new benchmark in patient care by integrating cutting-edge innovation with exceptional performance, ultimately leading to improved outcomes in vascular access.”

Michael Anstett, RN, Founder and Chief Clinical Officer of SkyDance, emphasized the clinical significance of the new system. “The Osprey Midline offers a genuine alternative to traditional midline devices. Its unique through-the-needle design provides tangible improvements in both safety and performance, and we are eager to witness the positive impact it will have across various healthcare environments.”

Healthcare professionals are already recognizing the potential of this innovation. Stephen Harris, RN, CRNI, VA-BC, Director of Research and Development at Vascular Wellness Management Solutions, offered his commendation: “The amazing strides SkyDance Vascular has made are truly impressive. I have been watching this company’s evolution for some time, and they continue to offer clinical solutions in a space where true innovation is rare. Congrats SkyDance!”

Following this FDA clearance, the Osprey Midline Closed IV Catheter System is now available in limited quantities. SkyDance Vascular remains dedicated to its mission of revolutionizing vascular access through the development of solutions focused on improving first-stick success, enhancing patient safety, and reducing complication rates.

About SkyDance Vascular
Founded in 2017, SkyDance Vascular has reimagined the Peripheral Intravenous Catheter (PIVC) with its Osprey product portfolio. By leveraging its proprietary Skin Avoidance Technology, the company aims to minimize insertion-related contamination, extend dwell times, improve therapy completion rates, and enhance patient satisfaction. SkyDance is led by a team of experienced executives, clinicians, engineers, and regulatory professionals with a proven history of success in the vascular access industry.
For more information, please visit www.skydancevascular.com or contact Bill Bold at bill.bold@skydancevascular.com.

About Stephen Harris, RN, CRNI, VA-BC
Stephen’s experience spans across the continuum of care, including acute and alternate care sites in vascular access. He holds 2 certifications involving vascular access and infusion and provides professional vascular access education. He is a long-time advocate for advancing vascular access practice and research on a local, regional, and national level.

Bill Bold
SkyDance Vascular, Inc.
+1 561-573-5360
bill.bold@skydancevascular.com
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