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FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

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FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
Business

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FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

2026-02-17 23:00 Last Updated At:23:15

MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United States.

PhenoMATRIX is an in vitro diagnostic software that uses artificial intelligence with laboratory-defined rules and clinical information to automatically sort images of bacterial culture plates, helping laboratory professionals streamline plate review while maintaining expert oversight.

The cleared intended use includes blood-based, chocolate and MacConkey agars, as well as CHROMagar orientation culture media plates, enabling semi-quantitative and qualitative image-based analysis through detection of microbial growth, estimation of colony counts, and differentiation of isolates based on phenotypic colony characteristics.

"This clearance represents a major milestone for Copan and microbiology laboratories in the United States," said Fabrizio Mazzocchi, CEO of Copan Diagnostics. "PhenoMATRIX builds on years of scientific development and real-world data to support laboratories and the critical work they do in patient care."

While PhenoMATRIX has been used globally for years as part of Copan's full laboratory automation solutions, including automated image review and auto-release workflows outside the United States, this clearance formally establishes its intended use in the U.S., where final image assessment and result decisions are performed by trained laboratory personnel.

Importantly, the FDA-cleared intended use represents an expansion beyond single-application algorithms, supporting multiple culture media plate types and integrating image analysis with patient data to assist laboratories in clinical microbiology review.

"This achievement is the result of an extraordinary collaborative effort," added Mario Savarese, CEO of Copan WASP, Copan's automation division. "Our Regulatory, R&D, Scientific Affairs, Quality, and Commercial teams worked tirelessly to support this submission. This clearance is a testament to their dedication and Copan's long-term vision."

Copan continues to invest in future submissions to expand the scope of PhenoMATRIX across additional applications and plate types, reinforcing its commitment to innovation and partnership with the clinical microbiology community.

For more information, visit copanusa.com.

About Copan Diagnostics, Inc. 

Copan Diagnostics is part of Copan Group, a leading manufacturer of collection and transport systems. Through its collaborative approach, Copan has developed breakthrough technologies such as FLOQSwabs®, ESwab®, UTM® Universal Transport Medium™, and WASPLab®, Full Laboratory Automation with Artificial Intelligence. Copan continues to innovate and transform collection and transport systems, and laboratory automation, helping healthcare providers improve patient care.

 

 

 

MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United States.

PhenoMATRIX is an in vitro diagnostic software that uses artificial intelligence with laboratory-defined rules and clinical information to automatically sort images of bacterial culture plates, helping laboratory professionals streamline plate review while maintaining expert oversight.

The cleared intended use includes blood-based, chocolate and MacConkey agars, as well as CHROMagar orientation culture media plates, enabling semi-quantitative and qualitative image-based analysis through detection of microbial growth, estimation of colony counts, and differentiation of isolates based on phenotypic colony characteristics.

"This clearance represents a major milestone for Copan and microbiology laboratories in the United States," said Fabrizio Mazzocchi, CEO of Copan Diagnostics. "PhenoMATRIX builds on years of scientific development and real-world data to support laboratories and the critical work they do in patient care."

While PhenoMATRIX has been used globally for years as part of Copan's full laboratory automation solutions, including automated image review and auto-release workflows outside the United States, this clearance formally establishes its intended use in the U.S., where final image assessment and result decisions are performed by trained laboratory personnel.

Importantly, the FDA-cleared intended use represents an expansion beyond single-application algorithms, supporting multiple culture media plate types and integrating image analysis with patient data to assist laboratories in clinical microbiology review.

"This achievement is the result of an extraordinary collaborative effort," added Mario Savarese, CEO of Copan WASP, Copan's automation division. "Our Regulatory, R&D, Scientific Affairs, Quality, and Commercial teams worked tirelessly to support this submission. This clearance is a testament to their dedication and Copan's long-term vision."

Copan continues to invest in future submissions to expand the scope of PhenoMATRIX across additional applications and plate types, reinforcing its commitment to innovation and partnership with the clinical microbiology community.

For more information, visit copanusa.com.

About Copan Diagnostics, Inc. 

Copan Diagnostics is part of Copan Group, a leading manufacturer of collection and transport systems. Through its collaborative approach, Copan has developed breakthrough technologies such as FLOQSwabs®, ESwab®, UTM® Universal Transport Medium™, and WASPLab®, Full Laboratory Automation with Artificial Intelligence. Copan continues to innovate and transform collection and transport systems, and laboratory automation, helping healthcare providers improve patient care.

 

 

 

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities

NEW YORK, Feb. 17, 2026 /PRNewswire/ -- As artificial intelligence reshapes the 21st century, Student B Press has launched Animal Intelligence, a cross-genre publishing project that revives animal fables and editorial cartoons as tools for reflection in the AI era.

Throughout history, moments of technological and social upheaval have given rise to allegory and satire—forms that return when language struggles to keep pace with change. Animal Intelligence reimagines these traditions through a contemporary publishing universe that blends philosophical fables and cartoons.

Observing Humanity in the Age of AI

The project's debut release, Watching Them Humans in the Age of AI, examines the present moment through satire. This short comic collection consists of two- and three-panel cartoons depicting animals as they observe human life shaped by artificial intelligence, ecological collapse, and growing societal anxiety.

Familiar figures from classic fables—such as foxes and turtles—reappear, asking whether humanity stands at a genuine turning point.

A Forgotten History, Told by Extinct Animals

The second volume, Animal Intelligence: The Book of Forgotten History, expands the project into a work of light philosophical fiction. Praised by Kirkus Reviews as "a rich and surprising alternative vision of the past," the book reconstructs human history through the imagined memories of extinct animals.

Spanning deep time to the modern age, the narrative presents histories known only to animals. Extinct animals such as dinosaurs and dodos recount their stories and serve as intellectual predecessors to the living animals who later appear in Watching Them Humans in the Age of AI.

The Animal Intelligence Project

Animal Intelligence is an experimental world-building project that invites readers to pause and reflect on human knowledge, contemporary anxiety, and the possibility of hope.

Published titles to date include Watching Them Humans in the Age of AI (comic collection), Animal Intelligence: The Book of Forgotten History (hybrid philosophical novel), and the Animal Intelligence Guidebook. Upcoming works will include narrative fiction in which animals attempt to save the world by learning from human knowledge.

The series is created by sibling collaborators Will Shin and Alice Shin. Will Shin, trained in artificial intelligence and public policy, believes storytelling is essential to creating space for reflective thinking about AI. Alice Shin leads the project's visual storytelling, adopting a deliberately "cute" illustrative style to lower barriers to engaging with complex subjects.

Contact: contentdirector@student-b.com 
Homepage: www.student-b.com

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

In the Age of AI, Animal Fables and Editorial Cartoons Return

In the Age of AI, Animal Fables and Editorial Cartoons Return

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