Latest news with #FDABreakthroughDeviceDesignation
Business Wire
3 hours ago
- Business
- Business Wire
Prevencio Awarded U.S., European and Japanese Patents for HART CADhs, Its AI-Driven Blood Test for Coronary Artery Disease
KIRKLAND, Wash.--(BUSINESS WIRE)-- Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular disease, today announced that it has been granted patents for its HART CADhs® test in the United States—marking the second U.S. patent for this novel test—as well as the European Union and Japan. These patents protect Prevencio's proprietary methods and algorithms for detecting obstructive coronary artery disease (CAD) using a multi-protein, AI-driven blood test platform. The newly issued patents strengthen Prevencio's intellectual property portfolio and support its long-term strategy to expand HART CADhs adoption globally. HART CADhs is the only blood test that combines multiple cardiac proteins with machine learning to deliver a highly accurate, non-invasive diagnosis of obstructive CAD. 'Securing patent protection in the U.S., Europe, and Japan marks a major step forward in advancing our innovation and market leadership,' said Rhonda Rhyne, Chief Executive Officer of Prevencio. 'These patents reinforce the uniqueness of our HART CADhs test and underscore our commitment to improving cardiovascular diagnostics worldwide.' Prevencio is redefining the future of cardiovascular diagnostics. With two marketed, AI-driven blood tests—HART CADhs and HART CVE—and bolstered by international patent protection, compelling clinical data, reimbursement, and recent FDA Breakthrough Device Designation, Prevencio uniquely delivers a convergence of innovation, validation, and commercial readiness. 'Cardiovascular disease is a global problem. International patent protection will help Prevencio to deliver scalable solutions that meet urgent diagnostic needs in the U.S. as well as global markets,' said James L. Januzzi, MD, a practicing cardiologist at MGH, Professor of Medicine at Harvard Medical School, Chief Scientific Officer at the Baim Institute for Clinical Research and Principal Investigator for the HART test development and validation. Cardiovascular disease remains the leading cause of death worldwide and accounts for more than $318 billion in annual U.S. healthcare costs, nearly 10% of total healthcare spending. Prevencio's HART blood tests are designed to improve accessibility, accuracy, and patient outcomes while reducing costs through earlier, more accessible, and accurate blood diagnostics. Both HART CADhs and HART CVE, a second AI-driven, multi-protein blood test that assesses a patient's one-year risk of heart attack, stroke, or cardiovascular death, are currently available to healthcare providers and for research use. About Prevencio, Inc. Prevencio is transforming cardiovascular care through AI-driven blood tests that deliver earlier, accurate, and more accessible diagnostics. The company's HART platform powers the development of proprietary tests for cardiovascular disease, including HART CADhs® for detecting obstructive coronary artery disease and HART CVE® for assessing one-year risk of heart attack, stroke, or cardiovascular death. For more information, visit Forward-Looking Statement: Except for historical and factual information contained herein, this press release contains forward-looking statements, the accuracy of which is subject to various uncertainties of early stage companies. The company does not undertake to update disclosures contained in this press release.
Arabian Business
17-04-2025
- Business
- Arabian Business
Burjeel Holdings partners with US AI firm Paige to transform cancer diagnostics in MENA
Burjeel Holdings announced a partnership with Paige, a US-based leader in next-generation AI technology, to enhance access to advanced cancer diagnostics. UAE healthcare major said it will deploy the US company's AI-powered solutions across its healthcare network. Burjeel, Paige join forces The partnership also seeks to address the global shortage of pathologists and accelerate access to rapid, reliable cancer diagnostics, particularly in underserved communities and emerging markets. Paige has developed a suite of AI applications that support diagnostic decision-making in cancer pathology. 'By incorporating next-gen AI into our pathology services, we aim to enhance the speed and accuracy of cancer diagnosis, enabling more effective treatment decisions,' said John Sunil, Group CEO of Burjeel Holdings. 'This partnership also reflects our mission to bring world-class, technology-enabled care to emerging markets,' he said. Peter Hamilton, General Manager of Diagnostics, Paige, said Burjeel Holdings' commitment to innovation and equitable care across the MENA region makes them a powerful ally in helping the company close diagnostic gaps and bring the benefits of our AI technology to more patients, faster. 'This partnership helps deliver on our mission to make next-generation cancer diagnostics accessible worldwide and aligns with our vision to standardise access to cutting-edge diagnostics on a global scale,' he said. Paige has earned multiple regulatory achievements in AI for pathology, including FDA Breakthrough Device Designation for Paige PanCancer Detect, Paige Breast Lymph Node, and Paige Prostate Detect. Burjeel Holdings said it will deploy these AI applications along with Paige OmniScreen, which simultaneously screens over 1,600 molecular biomarkers to support comprehensive cancer diagnosis and more personalised treatment.
Al Bawaba
17-04-2025
- Business
- Al Bawaba
Burjeel Holdings Partners with US-Based Paige to Deploy FDA-Approved AI in Cancer Diagnostics Across MENA
Burjeel Holdings, a leading super-specialty healthcare provider in the MENA region, has announced a strategic partnership with Paige, a US-based leader in next-generation AI technology. The collaboration aims to enhance access to advanced cancer diagnostics by deploying Paige's AI-powered solutions across Burjeel's healthcare network. It also seeks to address the global shortage of pathologists and accelerate access to rapid, reliable cancer diagnostics, particularly in underserved communities and emerging markets. The collaboration was announced during Abu Dhabi Global Health week in the presence of Dr. Shamsheer Vayalil, Founder and Chairman of Burjeel Holdings. Paige has developed a suite of AI applications that support diagnostic decision making in cancer pathology. Paige Prostate Detect*, a key component of the suite, is the first FDA-approved AI algorithm, that works by detecting prostate cancer in core-needle biopsies. With this partnership, Burjeel Holdings will become one of the first in the region to offer these AI-powered diagnostic tools, reinforcing its commitment to delivering timely and accessible cancer care. Paige's solutions are designed to augment the capabilities of pathologists, streamline workflows, and boost diagnostic confidence, ultimately resulting in better outcomes for patients. The partnership represents a significant step toward the democratization of advanced care, ensuring that even the most advanced technologies reach patients who need them most. 'Our collaboration with Paige represents a transformative step in delivering cancer diagnostics across our network. By incorporating next-gen AI into our pathology services, we aim to enhance the speed and accuracy of cancer diagnosis, enabling more effective treatment decisions. This partnership also reflects our mission to bring world-class, technology-enabled care to emerging markets,' said John Sunil, Group CEO of Burjeel Holdings. Paige has earned multiple regulatory achievements in AI for pathology, including FDA Breakthrough Device Designation for Paige PanCancer Detect, Paige Breast Lymph Node, and Paige Prostate Detect. Burjeel Holdings will deploy these AI applications along with Paige OmniScreen, which simultaneously screens over 1,600 molecular biomarkers to support comprehensive cancer diagnosis and more personalized treatment. 'Burjeel Holdings' commitment to innovation and equitable care across the MENA region makes them a powerful ally in helping us close diagnostic gaps and bring the benefits of our AI technology to more patients, faster. This partnership helps deliver on our mission to make next-generation cancer diagnostics accessible worldwide and aligns with our vision to standardize access to cutting-edge diagnostics on a global scale,' said Peter Hamilton, General Manager of Diagnostics, Paige. The partnership marks a key milestone in positioning Burjeel Holdings as a regional hub for AI-enabled pathology, with the potential to scale this transformative technology across MENA and beyond.
Emirates 24/7
16-04-2025
- Business
- Emirates 24/7
Burjeel Holdings Partners with US-Based Paige to Deploy FDA-Approved AI in Cancer Diagnostics Across MENA
Burjeel Holdings, a leading super-specialty healthcare provider in the MENA region, has announced a strategic partnership with Paige, a US-based leader in next-generation AI technology. The collaboration aims to enhance access to advanced cancer diagnostics by deploying Paige's AI-powered solutions across Burjeel's healthcare network. It also seeks to address the global shortage of pathologists and accelerate access to rapid, reliable cancer diagnostics, particularly in underserved communities and emerging markets. The collaboration was announced during Abu Dhabi Global Health week in the presence of Dr. Shamsheer Vayalil, Founder and Chairman of Burjeel Holdings. Paige has developed a suite of AI applications that support diagnostic decision making in cancer pathology. Paige Prostate Detect*, a key component of the suite, is the first FDA-approved AI algorithm, that works by detecting prostate cancer in core-needle biopsies. With this partnership, Burjeel Holdings will become one of the first in the region to offer these AI-powered diagnostic tools, reinforcing its commitment to delivering timely and accessible cancer care. Paige's solutions are designed to augment the capabilities of pathologists, streamline workflows, and boost diagnostic confidence, ultimately resulting in better outcomes for patients. The partnership represents a significant step toward the democratization of advanced care, ensuring that even the most advanced technologies reach patients who need them most. 'Our collaboration with Paige represents a transformative step in delivering cancer diagnostics across our network. By incorporating next-gen AI into our pathology services, we aim to enhance the speed and accuracy of cancer diagnosis, enabling more effective treatment decisions. This partnership also reflects our mission to bring world-class, technology-enabled care to emerging markets,' said John Sunil, Group CEO of Burjeel Holdings. Paige has earned multiple regulatory achievements in AI for pathology, including FDA Breakthrough Device Designation for Paige PanCancer Detect, Paige Breast Lymph Node, and Paige Prostate Detect. Burjeel Holdings will deploy these AI applications along with Paige OmniScreen, which simultaneously screens over 1,600 molecular biomarkers to support comprehensive cancer diagnosis and more personalized treatment. 'Burjeel Holdings' commitment to innovation and equitable care across the MENA region makes them a powerful ally in helping us close diagnostic gaps and bring the benefits of our AI technology to more patients, faster. This partnership helps deliver on our mission to make next-generation cancer diagnostics accessible worldwide and aligns with our vision to standardize access to cutting-edge diagnostics on a global scale,' said Peter Hamilton, General Manager of Diagnostics, Paige. The partnership marks a key milestone in positioning Burjeel Holdings as a regional hub for AI-enabled pathology, with the potential to scale this transformative technology across MENA and beyond. Follow Emirates 24|7 on Google News.
Zawya
16-04-2025
- Business
- Zawya
Burjeel Holdings partners with US-based Paige to deploy FDA-approved AI in cancer diagnostics across MENA
Abu Dhabi | New York: Burjeel Holdings, a leading super-specialty healthcare provider in the MENA region, has announced a strategic partnership with Paige, a US-based leader in next-generation AI technology. The collaboration aims to enhance access to advanced cancer diagnostics by deploying Paige's AI-powered solutions across Burjeel's healthcare network. It also seeks to address the global shortage of pathologists and accelerate access to rapid, reliable cancer diagnostics, particularly in underserved communities and emerging markets. The collaboration was announced during Abu Dhabi Global Health week in the presence of Dr. Shamsheer Vayalil, Founder and Chairman of Burjeel Holdings. Paige has developed a suite of AI applications that support diagnostic decision making in cancer pathology. Paige Prostate Detect*, a key component of the suite, is the first FDA-approved AI algorithm, that works by detecting prostate cancer in core-needle biopsies. With this partnership, Burjeel Holdings will become one of the first in the region to offer these AI-powered diagnostic tools, reinforcing its commitment to delivering timely and accessible cancer care. Paige's solutions are designed to augment the capabilities of pathologists, streamline workflows, and boost diagnostic confidence, ultimately resulting in better outcomes for patients. The partnership represents a significant step toward the democratization of advanced care, ensuring that even the most advanced technologies reach patients who need them most. 'Our collaboration with Paige represents a transformative step in delivering cancer diagnostics across our network. By incorporating next-gen AI into our pathology services, we aim to enhance the speed and accuracy of cancer diagnosis, enabling more effective treatment decisions. This partnership also reflects our mission to bring world-class, technology-enabled care to emerging markets,' said John Sunil, Group CEO of Burjeel Holdings. Paige has earned multiple regulatory achievements in AI for pathology, including FDA Breakthrough Device Designation for Paige PanCancer Detect, Paige Breast Lymph Node, and Paige Prostate Detect. Burjeel Holdings will deploy these AI applications along with Paige OmniScreen, which simultaneously screens over 1,600 molecular biomarkers to support comprehensive cancer diagnosis and more personalized treatment. 'Burjeel Holdings' commitment to innovation and equitable care across the MENA region makes them a powerful ally in helping us close diagnostic gaps and bring the benefits of our AI technology to more patients, faster. This partnership helps deliver on our mission to make next-generation cancer diagnostics accessible worldwide and aligns with our vision to standardize access to cutting-edge diagnostics on a global scale,' said Peter Hamilton, General Manager of Diagnostics, Paige. The partnership marks a key milestone in positioning Burjeel Holdings as a regional hub for AI-enabled pathology, with the potential to scale this transformative technology across MENA and beyond. * In the United States, Paige Prostate Detect (DEN200080) is approved for clinical use.
