The RedDrop One is a virtually pain-free, low cost, easy-to-use, whole blood and plasma collection and dispensing system. Credit: Innosphere Ventures/ Globe Newswire.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

The device is tailored to offer a less painful blood collection process for both patients and healthcare providers.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

A 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.”