NEW YORK — Tasso said on Tuesday that it has received CE marking for its TassoOne Plus at-home high-volume liquid blood collection device.
The device, the Seattle-based company said, is designed for the self-collection of capillary blood samples and is compatible with multiple standard collection tubes. The CE mark was received under the new medical device regulations adopted by the European Union last May.
"This CE mark unlocks clinical-grade liquid blood collection for decentralized clinical trials and home healthcare within the European Union, accelerating and expanding access to care," Tasso Cofounder and CEO Ben Casavant said in a statement.
Nearly two years ago, Tasso received the CE mark for its Tasso-M20 self-sampling blood collection device. In September, the company got 510(k) clearance from the US Food and Drug Administration for the Tasso+ blood collection device.