The US Food and Drug Administration (FDA) has granted 510(k) clearance to RedDrop Dx’s RedDrop One blood collection device, for prescription use.
This approval is a milestone for RedDrop Dx, an Innosphere Ventures Client Company, signifying a leap forward in blood collection technology and patient care.
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It follows a 90-day review by the FDA.
RedDrop One is a pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system.
It is designed to facilitate the collection of larger blood volumes, with enhanced reliability and less discomfort for patients.
The device is tailored to offer a less painful blood collection process for both patients and healthcare providers.
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By GlobalDataA clinical trial involving 100 participants underpinned the effectiveness of RedDrop One for self-collection of blood samples, achieving a 97% success rate when users adhered to the device’s instructions.
RedDrop One is suitable for various settings, including home health, point-of-care, centralised, and remote clinical trial testing.
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 decentralised 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 realising the potential of remote testing.”
