Tasso today announced that the FDA has cleared its Tasso+ lancet blood collection system as a Class II medical device.
Seattle-based Tasso designed its device for single-use, patient-centered blood collection. It offers a simple and virtually painless blood collection experience.
The company said in a press release that Tasso+ is the first device of its kind to receive Class II clearance from the FDA under a new reclassification process. The classification covers lancets intended to pierce the skin to obtain drops of capillary blood samples.
This is all part of the FDA’s efforts to ensure the safe and effective use of lancets in homes and healthcare settings. Tasso said the clearance allows drug companies to speed up decentralized clinical trials. Additionally, healthcare systems and physicians can use Tasso+ with compatible collection tubes to perform blood chemistry determinations.
Tasso intends to make the solutions widely available to customers across the United States during the fourth quarter of this year.
“With continued industry interest in decentralized clinical trials and various testing applications, demand for our high-quality, virtually painless and 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 bottlenecks associated with phlebotomy and enabling more people to get the tests they need when they need it. they are necessary. We are excited to unlock a new wave of significant business opportunities for the company and lead the industry into the future of remote testing.