Latest news with #Pramana
National Post
6 days ago
- Business
- National Post
Pramana Receives Health Canada Authorization for Digital Pathology Scanners
Article content CAMBRIDGE, Mass. — Pramana, an AI-enabled health tech company modernizing the pathology sector, today announced it has received Health Canada Medical Device Licenses for its flagship digital pathology scanners, the SpectralM and SpectralHT Cubiq systems. The approval authorizes Pramana to import, market, and sell its devices in Canada, expanding access to its advanced imaging and workflow solutions. Article content Health Canada authorization is required to commercialize Class II medical devices and affirms the product's safety, effectiveness, and quality. The approval opens the door for Pramana to support Canadian hospitals, pathology labs, and research institutions, helping modernize diagnostic workflows with scalable, AI-powered digital pathology tools. This recognition marks a critical step in Pramana's international expansion, building on its growing regulatory footprint. Article content 'Receiving Health Canada authorization is a major milestone in our commercialization strategy,' said Prasanth Perugupalli, Chief Product Officer at Pramana. 'It reflects the strength of our product development, quality, and regulatory readiness, and it opens the door to expanding access to our technology in a market known for strong clinical and academic institutions.' Article content Pramana's scanners are designed to digitize a wide range of pathology slides, producing high-resolution whole-slide images with automated quality control and AI-powered decision support. The platform supports both FFPE tissue and Liquid Based Cytology (LBC) samples prepared using methods such as the ThinPrep® Pap test (Hologic) and BD SurePath™ (Becton Dickinson). Unlike most digital pathology systems focused solely on anatomic pathology, Pramana expands digital workflows to include hematopathology, microbiology, and cytology, delivering flexibility across all major slide types. Article content 'Our research at the University of Toronto highlights the need for adaptable platforms that can manage these technical demands while still supporting routine histology and cytology workflows,' said Dr. Carlo Hojilla, Consultant Pathologist at the University of Toronto. 'Pramana's technology meets that standard, and its Health Canada authorization reflects both its clinical utility and the rigorous quality required for widespread adoption.' Article content Prior to receiving Health Canada authorization, Pramana secured Medical Device Single Audit Program (MDSAP) certification, a requirement that validated its quality management system and streamlined regulatory access in Canada, the United States, Brazil, Australia, and Japan, highlighting Pramana's commitment to modernizing digital pathology worldwide. Article content To discover how Pramana's whole-slide imaging solution can help healthcare organizations across Canada, visit Article content About Pramana, Inc. Article content Pramana is a health tech company transforming digital pathology with AI-powered imaging solutions that support seamless adoption across labs, health systems, and medical centers. Pramana's Spectral scanners deliver industry-leading image quality and unprecedented accuracy. Built-in AI algorithms and automated quality control streamline workflows, increase efficiency, and capture previously undetectable tissue features, empowering pathologists with the tools needed to improve clinical diagnostics and research. The company is headquartered in Cambridge, Mass. For more information, visit Article content Article content Article content Article content Article content Article content
Business Wire
6 days ago
- Business
- Business Wire
Pramana Receives Health Canada Authorization for Digital Pathology Scanners
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Pramana, an AI-enabled health tech company modernizing the pathology sector, today announced it has received Health Canada Medical Device Licenses for its flagship digital pathology scanners, the SpectralM and SpectralHT Cubiq systems. The approval authorizes Pramana to import, market, and sell its devices in Canada, expanding access to its advanced imaging and workflow solutions. Health Canada authorization is required to commercialize Class II medical devices and affirms the product's safety, effectiveness, and quality. The approval opens the door for Pramana to support Canadian hospitals, pathology labs, and research institutions, helping modernize diagnostic workflows with scalable, AI-powered digital pathology tools. This recognition marks a critical step in Pramana's international expansion, building on its growing regulatory footprint. 'Receiving Health Canada authorization is a major milestone in our commercialization strategy,' said Prasanth Perugupalli, Chief Product Officer at Pramana. 'It reflects the strength of our product development, quality, and regulatory readiness, and it opens the door to expanding access to our technology in a market known for strong clinical and academic institutions.' Pramana's scanners are designed to digitize a wide range of pathology slides, producing high-resolution whole-slide images with automated quality control and AI-powered decision support. The platform supports both FFPE tissue and Liquid Based Cytology (LBC) samples prepared using methods such as the ThinPrep® Pap test (Hologic) and BD SurePath™ (Becton Dickinson). Unlike most digital pathology systems focused solely on anatomic pathology, Pramana expands digital workflows to include hematopathology, microbiology, and cytology, delivering flexibility across all major slide types. 'Our research at the University of Toronto highlights the need for adaptable platforms that can manage these technical demands while still supporting routine histology and cytology workflows,' said Dr. Carlo Hojilla, Consultant Pathologist at the University of Toronto. 'Pramana's technology meets that standard, and its Health Canada authorization reflects both its clinical utility and the rigorous quality required for widespread adoption.' Prior to receiving Health Canada authorization, Pramana secured Medical Device Single Audit Program (MDSAP) certification, a requirement that validated its quality management system and streamlined regulatory access in Canada, the United States, Brazil, Australia, and Japan, highlighting Pramana's commitment to modernizing digital pathology worldwide. To discover how Pramana's whole-slide imaging solution can help healthcare organizations across Canada, visit About Pramana, Inc. Pramana is a health tech company transforming digital pathology with AI-powered imaging solutions that support seamless adoption across labs, health systems, and medical centers. Pramana's Spectral scanners deliver industry-leading image quality and unprecedented accuracy. Built-in AI algorithms and automated quality control streamline workflows, increase efficiency, and capture previously undetectable tissue features, empowering pathologists with the tools needed to improve clinical diagnostics and research. The company is headquartered in Cambridge, Mass. For more information, visit
Toronto Star
07-05-2025
- Health
- Toronto Star
Pramana Strengthens Scientific Leadership with Addition of Dr. Adrian Noriega to Advance Neurodegenerative Pipeline
VANCOUVER, British Columbia, May 07, 2025 (GLOBE NEWSWIRE) — Pramana Pharmaceuticals, a late-stage preclinical biopharmaceutical company developing a transformative small molecule platform targeting the intersection of metabolism, immunity, and neurodegeneration, today announced the appointment of Adrian Noriega, M.D., Ph.D., to its senior scientific advisory board. Dr. Noriega's expertise in Alzheimer's disease, vascular neurology, and biomarker-driven strategy marks a key milestone in Pramana's neurodegenerative expansion. With this appointment, Pramana further strengthens its world-class scientific team spanning metabolic disease, cardiovascular biology, and neurology. Together, this group is advancing a bold vision: to transform chronic disease treatment using a first-in-class, oral GPR119 agonists designed as 'smart molecules' for glycemic control and beyond.
Associated Press
11-03-2025
- Business
- Associated Press
Pramana and ARUP Laboratories Partner to Digitize Pathology Slides and Develop AI-Powered Hematopathology Algorithms for Deployment via Edge AI
CAMBRIDGE, Mass. & SALT LAKE CITY--(BUSINESS WIRE)--Mar 11, 2025-- Pramana, Inc., an AI-enabled health tech company modernizing the pathology sector, and ARUP Laboratories, the largest nonprofit clinical and academic reference laboratory in the United States, announced a collaboration to digitize pathology slides and develop AI-powered algorithms to improve the assessment of bone marrow biopsies and address other key diagnostic challenges in hematopathology. The partnership combines ARUP's hematopathology expertise with Pramana's cutting-edge SpectralHT autonomous whole-slide imaging scanners to advance diagnostic precision and efficiency. This press release features multimedia. View the full release here: 'Hematopathology involves highly complex and difficult-to-scan specimens, where traditional methods often fall short in delivering consistent and reproducible results,' said David Ng, MD, medical director of Hematologic Flow Cytometry and Applied Artificial Intelligence at ARUP Laboratories. 'By combining our deep clinical expertise with Pramana's large-scale digitization and AI-driven analysis, we have the ability to develop and clinically validate new AI algorithms that will improve diagnostic accuracy and workflow efficiency. Additionally, this collaboration lays the foundation for the broad distribution of these AI tools, ensuring greater accessibility and impact across the pathology community.' The AI model development process will be led by ARUP, drawing on its expert hematopathologists and annotation tools to train, refine, and validate the algorithms using real-world clinical cases and pathology slides obtained for this purpose. These algorithms will be designed and tested to run efficiently on Pramana's SpectralHT scanners, demonstrating the viability of in-line edge computing for real-time AI-powered diagnostics. ARUP and Pramana will explore commercialization strategies to enable the seamless deployment and distribution of advanced diagnostic algorithms per regulatory standards, which will run efficiently on scanners and drive broader industry adoption in clinical diagnostics. 'This collaboration with ARUP Laboratories showcases how AI-driven pathology can redefine industry standards, making diagnostics more scalable, efficient, and interoperable,' said Prasanth Perugupalli, chief product officer at Pramana. 'By leveraging edge computing, we're accelerating the adoption of advanced diagnostic algorithms, including those for complex hematopathology cases. This approach enhances precision, removes scalability barriers, and seamlessly integrates AI-driven insights into lab workflows.' Pramana's SpectralHT scanners feature in-line Edge AI computing, allowing real-time quality control and automated image processing. This streamlined workflow reduces the burden on lab personnel while ensuring high-quality data output. The SpectralHT scanners' volumetric imaging capabilities improve image quality and detail while enhancing scanning efficiency, even for the most challenging diagnostic slides, such as microbiology, hematopathology, parasitology, and cytology. The ongoing partnership between ARUP Laboratories and Pramana underscores a broader commitment to digitization and AI-driven pathology advancements, signaling the potential for deeper integration and expanded initiatives, including clinical applications. About Pramana, Inc. Pramana, Inc., an AI-powered health tech company modernizing the pathology sector, enables seamless digital adoption by pathology labs and medical centers. Built upon extensive industry experience and patented technological innovation, Pramana is a gateway for pathologists and physicians to utilize AI-enabled decision support. The company is headquartered in Cambridge, Mass., and backed by Matrix Capital, a global leader in customized investment solutions, and NTTVC, a leading firm backing diverse founders within the technology spectrum. For more information, visit About ARUP Laboratories Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah's Spencer Fox Eccles School of Medicine and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™. ARUP is ISO 15189 and CAP accredited. For more information, visit Pramana: Andrea Sampson, Sampson PR Group [email protected]: Bonnie Stray KEYWORD: UNITED STATES NORTH AMERICA UTAH MASSACHUSETTS INDUSTRY KEYWORD: RESEARCH TECHNOLOGY MEDICAL DEVICES HEALTH TECHNOLOGY SOFTWARE BIOTECHNOLOGY HEALTH SCIENCE ONCOLOGY ARTIFICIAL INTELLIGENCE SOURCE: Pramana Copyright Business Wire 2025. PUB: 03/11/2025 08:10 AM/DISC: 03/11/2025 08:09 AM
