US-based medical equipment manufacturer RedDrop Dx has received the US Food and Drug Administration (FDA) 510(k) approval for its advanced blood collection device, RedDrop One.
RedDrop One, the company’s first product, is a prescription-use whole blood and plasma collection device for delivering whole blood and plasma.
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It is a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system for home health, point-of-care, centralised, and remote clinical trials.
Unlike traditional blood collection methods, the device offers several key advantages including the ability to collect a large blood volume, enhanced reliability, and reduced user discomfort.
RedDrop Dx CEO and co-founder Kris Buchanan said: “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 Dx said that the FDA approval marks a significant towards enhancing blood collection technology and patient care practices.
Its RedDrop One is designed to offer a more effective and less painful blood collection experience, to address the needs of both patients and healthcare providers.
It is suitable for a wide range of settings, including Home Health, Point-of-Care, Centralized, and Remote Clinical Trials testing, said the medical device maker.
The FDA approval of the RedDrop One device followed a complete 90-day review process.
The effectiveness of the device for self-collection of blood samples was supported by a clinical trial with 100 participants, showing a 97% success rate, said RedDrop Dx.
