Tasso has obtained CE mark certification for its latest generation, virtually pain-free whole blood collection lancet device, Tasso+.
The device is intended for collecting whole liquid blood samples.
Meanwhile, the certification enables the company to market its patient-centric, high-volume blood collection solution in the European Union market, including 28 member states, as well as in Lichtenstein, Iceland and Norway.
Designed to obtain microliter capillary whole blood samples, the single-use blood-lancing device facilitates the collection of virtually painless blood samples with a user-friendly interface.
Furthermore, the device is suitable for use with compatible collection tubes to expedite decentralised clinical trials for pharmaceutical companies, specifically for pharmacokinetic and biomarker research endpoints.
It also helps physicians and healthcare systems determine the blood chemistry of their patients and expand access to care.
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By GlobalDataTasso CEO and co-founder Ben Casavant said: “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.
“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.”
In August last year, the company received Class II 510(k) clearance from the US Food and Drug Administration for this lancet device.