FDA Clears RedDrop Dx, Inc.’s Blood Collection Device, RedDrop One
Fort Collins, CO, March 22, 2024 (GLOBE NEWSWIRE) -- RedDrop Dx , Inc., Innosphere Ventures Client Company, is pleased to announce that its innovative blood collection device, RedDrop One, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for prescription use.
Fort Collins, CO, March 22, 2024 (GLOBE NEWSWIRE) -- RedDrop Dx, Inc., Innosphere Ventures Client Company, is pleased to announce that its innovative blood collection device, RedDrop One, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for prescription use. This clearance marks a significant step forward for RedDrop Dx in enhancing blood collection technology and patient care practices.
RedDrop One offers several key 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 healthcare providers by offering a more efficient and less painful blood collection experience.
The effectiveness of RedDrop One for self-collection of blood samples 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 comprehensive 90-day review process by the FDA.
Kris Buchanan, CEO and co-founder of RedDrop Dx, commented on the clearance, stating, “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. 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.”
RedDrop One is RedDrop Dx's premier product, embodying the company's commitment to creating solutions that are virtually pain-free, cost-effective, and easy to use for the collection and dispensing of whole blood and plasma. It is suitable for a wide range of settings, including Home Health, Point-of-Care, Centralized, and Remote Clinical Trials testing.
About RedDrop Dx, Inc.: Located in Fort Collins, Colorado, RedDrop Dx, Inc. is at the forefront of developing medical devices that aim to improve the patient care experience. With RedDrop One, the company introduces an innovative approach to blood collection, prioritizing accessibility, convenience, and reduced patient discomfort. RedDrop Dx is dedicated to advancing healthcare solutions that benefit both patients and healthcare professionals.
For more information about RedDrop Dx and the RedDrop One device, please visit https://www.reddropdx.com/
Attachments
Kris Buchanan RedDrop Dx 9704438118 [email protected]