Clearance marks a pivotal step in bringing to market the world’s first benchtop analyzer capable of running chemistries, immunoassays, and hematology in a single device
Truvian Health announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K251058) for TruVerus, the industry’s first multimodal blood testing benchtop instrument. This clearance represents a major milestone in Truvian’s mission to deliver a full menu of routine blood testing results wherever care happens.
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“Accomplishment of this milestone represents a critical turning point for Truvian, validating years of rigorous development and our unwavering commitment to transparency and trust,” said Dena Marrinucci, Ph.D., Co-Founder and Chief Operating Officer.
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TruVerus integrates multiple testing modalities – chemistries, immunoassays and hematology assays –into a single, compact, plug-and-play instrument, delivering comprehensive results from a small sample of blood in minutes. TruVerus makes lab-quality testing practical for decentralized care settings and is intended to reduce cost and complexity.
As part of this initial clearance, the Tru Analyzer, marketed under the trade name TruVerus, includes its first test panel focused on kidney health. Additional panels have been submitted for FDA review, and Truvian is pursuing staged clearances as part of its strategy to deliver a broad menu of assays on a single benchtop platform.
“Accomplishment of this milestone represents a critical turning point for Truvian, validating years of rigorous development and our unwavering commitment to transparency and trust,” said Dena Marrinucci, Ph.D., Co-Founder and Chief Operating Officer of Truvian. “Every claim we’ve made has been backed by data, and this achievement marks a major step toward our mission to redefine how and where routine blood testing can be delivered, making it more convenient and accessible for patients everywhere.”
“Truvian is poised to disrupt the diagnostics industry by creating a future where full lab testing is decentralized, improving access, and providing results in minutes, while using only a fraction of the blood needed for other routine blood testing,” said Michael J. Mina, MD, Ph.D., one of the leading diagnostics and industry experts and member of Truvian’s scientific advisory board. “This boldly empowers providers to deliver faster, more informed, and ultimately, more equitable care.”
With TruVerus now cleared, Truvian intends to continue expanding its assay menu through additional FDA clearances, advancing its mission to deliver comprehensive testing at a price point that supports decentralized care models.
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Source- businesswire
