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RedDrop Dx Gets US FDA 510(k) Clearance for Blood Sample Self-Collection Device

NEW YORK – RedDrop Dx said Friday that the firm has secured US Food and Drug Administration 510(k) clearance for its blood collection device.

The Fort Collins, Colorado-based firm said that its RedDrop One instrument is suitable for at-home use, at the point of care, for centralized testing, and for remote clinical trial settings. The device, it said, has the ability to collect a larger volume of blood more easily than traditional blood collection devices.

According to RedDrop, the device can help to improve access to patient samples for essential tests as well as participation in decentralized clinical trials. The company said that its application for clearance had been supported by a clinical trial with 100 patients and the device had a 97 percent success rate when patients followed the device's use instructions.

RedDrop CEO Kris Buchanan said in a statement that RedDrop One will help improve patient care by making blood collection more accessible and reliable and less painful.

"Demand for RedDrop One has never been higher as the industry has become more aware of our breakthrough technology," Buchanan said. "We look forward to leading the industry and realizing the potential of remote testing."