Designation expands the availability of Tasso’s patient-centric blood collection solution for decentralized clinical trials, home diagnostic testing, wellness and anti-doping uses to the European Union
The Tasso+ device received Class II 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2022. (Credit: National Cancer Institute on Unsplash)
Tasso, the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+ device, a convenient, virtually pain-free blood lancet that collects whole liquid blood samples.
The CE Mark designation allows Tasso to offer its patient-centric, high-volume blood collection solution in the European Union (EU) market, which includes 28 member states, plus Iceland, Norway, and Lichtenstein. The CE Mark designation ensures a product has met all European Commission safety, health, and environmental protection requirements.
The Tasso+ device received Class II 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August 2022. With the CE Mark certification, Tasso+ now has achieved full clearance in the U.S. and the EU, making it the first device of its kind to do so.
“This designation is an important milestone for Tasso, allowing us to build upon the success of our CE Marked Tasso-M20 device and continue to expand our commercial footprint and reduce healthcare access barriers in Europe, where demand increasingly grows for patient-centric solutions,” said Ben Casavant, PhD, CEO and co-founder of Tasso. “The Tasso+ CE Mark enables us to support the pharmaceutical industry, academic and government institutions on research and clinical initiatives, as well as accelerate access to remote testing and care for more patient populations. We are excited to expand our customer base in Europe.”
The Tasso+ device is a single-use blood lancing device for obtaining microliter capillary whole blood samples. Based on groundbreaking technology, Tasso+ allows for virtually painless blood samples to be collected remotely, with a user-friendly interface that boosts satisfaction and engagement.
The device can be used with compatible collection tubes to accelerate decentralized clinical trials for pharmaceutical companies, especially for pharmacokinetic and biomarker research endpoints. With a patient-centric collection process that overcomes care access barriers, Tasso+ enables underserved and understudied patient populations to participate in clinical trials. In addition, healthcare systems and physicians can use the Tasso+ device to make determinations on blood chemistries for their patients and expand access to care.
Source: Company Press Release