Pramana Receives Health Canada Authorization for Digital Pathology Scanners
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.
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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.
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'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.'
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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.
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'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.'
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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.
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To discover how Pramana's whole-slide imaging solution can help healthcare organizations across Canada, visit explore.pramana.ai/health-canada.
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About Pramana, Inc.
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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 pramana.ai.
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Toronto Sun
an hour ago
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As Trump's trade deal deadline approaches, his tariffs face legal pushback in court
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Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. SUBSCRIBE TO UNLOCK MORE ARTICLES Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. REGISTER / SIGN IN TO UNLOCK MORE ARTICLES Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account. Share your thoughts and join the conversation in the comments. Enjoy additional articles per month. Get email updates from your favourite authors. THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK. Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account Share your thoughts and join the conversation in the comments Enjoy additional articles per month Get email updates from your favourite authors Don't have an account? Create Account While Trump set an Aug. 1 deadline for countries to make trade deals with the United States, the president's ultimatum has so far resulted in only a handful of frameworks for trade agreements. Deals have been announced for Japan, Vietnam, Indonesia, the Philippines and the United Kingdom — but Trump indicated last week that an agreement with Canada is far from complete. 'We don't have a deal with Canada, we haven't been focused on it,' Trump told reporters Friday. Trump sent a letter to Prime Minister Mark Carney threatening to impose 35 per cent tariffs if Canada doesn't make a trade deal by the deadline. 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Global News
2 hours ago
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As Trump's trade deal deadline approaches, his tariffs face legal pushback in court
Donald Trump's plan to realign global trade faces its latest legal barrier this week in a federal appeals court — and Canada is bracing for the U.S. president to follow through on his threat to impose higher tariffs. While Trump set an Aug. 1 deadline for countries to make trade deals with the United States, the president's ultimatum has so far resulted in only a handful of frameworks for trade agreements. Deals have been announced for Japan, Vietnam, Indonesia, the Philippines and the United Kingdom — but Trump indicated last week that an agreement with Canada is far from complete. 'We don't have a deal with Canada, we haven't been focused on it,' Trump told reporters Friday. Trump sent a letter to Prime Minister Mark Carney threatening to impose 35 per cent tariffs if Canada doesn't make a trade deal by the deadline. The White House has said those duties would not apply to goods compliant with the Canada-U.S.-Mexico Agreement on trade. Story continues below advertisement Canadian officials have also downplayed expectations of a new economic and security agreement materializing by Friday. 'We'll use all the time that's necessary,' Carney said last week. Countries around the world will also be watching as Trump's use of a national security statute to hit nations with tariffs faces scrutiny in the United States Court of Appeals for the Federal Circuit. The U.S. Court of International Trade ruled in May that Trump does not have the authority to wield tariffs on nearly every country through the use of the International Economic Emergency Powers Act of 1977. Get daily National news Get the day's top news, political, economic, and current affairs headlines, delivered to your inbox once a day. Sign up for daily National newsletter Sign Up By providing your email address, you have read and agree to Global News' Terms and Conditions and Privacy Policy The act, usually referred to by the acronym IEEPA, gives the U.S. president authority to control economic transactions after declaring an emergency. No previous president had ever used it for tariffs and the U.S. Constitution gives power over taxes and tariffs to Congress. The Trump administration quickly appealed the lower court's ruling on the so-called 'Liberation Day' and fentanyl-related tariffs and arguments are set to be heard in the appeal court on Thursday. The hearing combines two different cases that were pushing against Trump's tariffs. One involves five American small businesses arguing specifically against Trump's worldwide tariffs, and the other came from 12 states pushing back on both the 'Liberation Day' duties and the fentanyl-related tariffs. Story continues below advertisement George Mason University law professor Ilya Somin called Trump's tariff actions a 'massive power grab.' Somin, along with the Liberty Justice Center, is representing the American small businesses. 'We are hopeful — we can't know for sure obviously — we are hopeful that we will continue to prevail in court,' Somin said. Somin said they are arguing that IEEPA does not 'give the president the power to impose any tariff he wants, on any nation, for any reason, for as long as he wants, whenever he feels like it.' He added that 'the law also says there must be an emergency and an unusual and extraordinary threat to American security or the economy' — and neither the flow of fentanyl from Canada nor a trade deficit meet that definition. U.S. government data shows a minuscule volume of fentanyl is seized at the northern border. The White House has said the Trump administration is legally using powers granted to the executive branch by the Constitution and Congress to address America's 'national emergencies of persistent goods trade deficits and drug trafficking.' There have been 18 amicus briefs — a legal submission from a group that's not party to the action — filed in support of the small businesses and states pushing against Trump's tariffs. Two were filed in support of the Trump administration's actions. Story continues below advertisement Brent Skorup, a legal fellow at the Washington-based Cato Institute, said the Trump administration is taking a vague statute and claiming powers never deployed by a president before. The Cato Institute submitted a brief that argued 'the Constitution specifies that Congress has the power to set tariffs and duties.' Skorup said there are serious issues with the Trump administration's interpretation of IEEPA. 'We don't want power consolidated into a single king or president,' he said. It's expected the appeals court will expedite its ruling. Even if it rules against the duties, however, they may not be immediately lifted. White House Press Secretary Karoline Leavitt has said the Supreme Court should 'put an end to this.' There are at least eight lawsuits challenging the tariffs. Canada is also being hit with tariffs on steel, aluminum and automobiles. Trump used different powers under the Trade Expansion Act of 1962 to enact those duties.
