FDA clears RedDrop’s blood-collection device

FORT COLLINS — RedDrop Dx Inc., a Fort Collins-based client and portfolio company of Innosphere Ventures, has received clearance from the U.S. Food and Drug Administration for its blood-collection device, RedDrop One.

According to the company, the device offers several advantages over traditional blood-collection methods, including the ability to collect a larger volume of blood more easily with increased reliability and reduced discomfort for the user. The device is designed to meet the needs of both patients and health-care providers by offering a more efficient and less painful blood-collection experience.

The device’s effectiveness was supported by a clinical trial with 100 participants, demonstrating a 97% success rate when following the device’s Instructions for use. The device’s approval followed a 90-day review process by the FDA.

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“Receiving FDA Class II medical-device clearance for RedDrop One, our industry-leading solution, allows us to play a crucial role in improving patient care by making blood collection more accessible, reliable, less painful and with the highest quality,” Kris Buchanan, CEO and co-founder of RedDrop Dx, said in a prepared statement. “This is particularly important for supporting decentralized clinical trials and a variety of testing applications, where our technology can help overcome common obstacles related to phlebotomy and ensure timely access to essential tests. Demand for RedDrop One has never been higher as the industry has become more aware of our breakthrough technology. We look forward to leading the industry and realizing the potential of remote testing.”

Innosphere Ventures is a 501(c)(3) nonprofit that accelerates the success of founders and university researchers who are launching and scaling science and technology-based startup companies with regional, industry-specific incubation programs, office and specialized wet laboratory facilities, and venture capital funds.