Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

Thursday, September 15, 2022

Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, announced today that its Tasso+™ lancet has received clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device. This regulatory milestone allows the company to market and distribute the Tasso+ lancet to a wider range of pharmaceutical companies, healthcare organizations, and academic institutions across the United States. The clearance will expand access to a simple and virtually painless blood collection experience for patients.

The Tasso+ device is the first patient-centric, single-use blood collection product to receive Class II clearance from the FDA under the new reclassification process for lancets. Lancets are designed to puncture the skin and obtain drops of capillary blood samples. The FDA's action is part of its ongoing efforts to ensure the safe and effective use of lancets in home and healthcare settings. With this clearance, pharmaceutical companies can expedite decentralized clinical trials, particularly for pharmacokinetic and biomarker research endpoints. Healthcare systems and physicians can also utilize the Tasso+ device, along with compatible collection tubes, to make determinations on blood chemistries for their patients, thereby enhancing access to care. Tasso+ device-based solutions with Class II clearance will be widely available to customers throughout the country starting in the fourth quarter of 2022.

Ben Casavant, PhD, CEO and co-founder of Tasso, expressed the company's enthusiasm for the continued industry interest in decentralized clinical trials and diverse testing applications. He highlighted the high demand for Tasso's high-quality, virtually painless, and convenient blood collection solutions. The FDA's Class II medical device clearance is expected to enhance patient care by addressing traditional phlebotomy-related bottlenecks and enabling more individuals to undergo necessary tests at the right time. Casavant further emphasized Tasso's commitment to unlocking new commercial opportunities and leading the industry into the future of remote testing.

With the FDA's clearance, Tasso, Inc. is well-positioned to advance the field of blood collection and revolutionize the patient experience in obtaining blood samples for various medical purposes.

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