Tasso announced today that the FDA cleared its Tasso+ lancet blood collection system as a Class II medical device.
Seattle-based Tasso designed its device for single-use, patient-centric blood collection. It provides a simple, virtually painless blood collection experience.
The company said in a news release that Tasso+ is the first device of its kind to receive Class II FDA clearance as part of a new reclassification process. The classification covers lancets intended to puncture the skin to obtain drops of capillary blood samples.
It all comes as part of the FDA’s effort to ensure the safe and effective use of lancets in the home and healthcare settings. Tasso said clearance allows pharmaceutical companies to accelerate decentralized clinical trials. Additionally, healthcare systems and physicians can use Tasso+ with compatible collection tubes to make determinations on blood chemistries.
Tasso intends to make the solutions widely available to customers across the U.S. in the fourth quarter of this year.
“With continued industry interest in decentralized clinical trials and diverse testing applications, demand for our high-quality, virtually painless, convenient blood collection solutions is at an all-time high,” said Ben Casavant, CEO and co-founder of Tasso. “This FDA Class II medical device clearance will help improve patient care by relieving traditional phlebotomy-related bottlenecks and enabling more individuals to get the tests they need at the time they are needed. We are excited to unlock a new wave of large commercial opportunities for the company and to lead the industry into the future of remote testing.”