Latest news with #FDABreakthroughDeviceDesignation
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.
Yahoo
18-03-2025
- Health
- Yahoo
Teal Health Unveils Landmark Study Results Showing Teal Wand™ Self-Collected Samples Match Clinician Collected Samples
SELF-CERV study validates the Teal Wand at-home cervical cancer screening as a preferred and viable alternative to in-person screening. SAN FRANCISCO, March 18, 2025 /PRNewswire/ -- Teal Health, a women's health company on a mission to eradicate cervical cancer by bringing at-home cervical cancer screening to the US, announced groundbreaking clinical trial results at the Eurogin International Multidisciplinary HPV Conference, revealing that its Teal Wand™ self-collected cervical screening samples perform equivalently to clinician-collected samples. This milestone underscores Teal Health's mission to revolutionize cervical cancer screening by providing a convenient, at-home solution that aligns with the current gold-standard testing used in clinics. Teal Health's at-home cervical cancer screening device received the FDA Breakthrough Device Designation, recognizing both its strong clinical data and importance to public health. The company's study—the largest nation-wide comparative study in the U.S. with over 600 participants—demonstrated that self-collected sample results matched those of clinician collected samples tested on the Roche Cobas HPV Assay. Leading medical guidelines, including USPSTF and the American Cancer Society (ACS) recognize HPV testing as the most sensitive cervical cancer screening test at 95% sensitivity, which exceeds the traditional Pap smear of 55%. Pap smears can only be collected by a clinician, whereas HPV samples can be self-collected. Key clinical findings from the Teal Health SELF-CERV study include: Teal Wand's clinical sensitivity is 96%, matching the performance of clinician-collected samples, which is also 96%. Clinical sensitivity is the measure of the HPV test's ability to correctly identify women who have developed cervical cancer or precancer. Self-collected sample agreement of 95% with clinician-collected samples, surpassing the threshold for equivalency, set at 87%. High usability, with 99% reporting no difficulty, 92% completed collection in under 5 minutes, and 98% of self-collected samples being valid for analysis, demonstrating strong patient understanding and capability to perform the self-collection. Beyond performance metrics, the study also highlighted a significant preference among women for at-home screening. An overwhelming 94% of participants indicated they would choose Teal Health's self-collection option if they knew it provided the same accuracy as a clinician-collected sample, and 86% reported they would be more likely to stay up-to-date with routine screening if an at-home option were available. These statistics show the need for diverse screening options. Teal prioritized inclusion in the SELF-CERV study, ensuring clinical trial participants represented the US population across race, ethnicity, gender, income, and geography. While current HPV screening methods effectively detect pre-cancer with up to 95% sensitivity, the traditional in-office approach has resulted in nearly one in three women falling behind on their screenings. Unlike other cancer screenings that rebounded after the COVID-19 pandemic, cervical cancer screening rates remain stagnant, with barriers such as appointment availability, time constraints, and discomfort with the speculum exam deterring many women from routine care. Teal Health's at-home alternative which couples a telehealth platform with the Teal Wand directly addresses these challenges, offering a comfortable, accessible, and clinically validated alternative that could significantly improve screening participation rates for this nearly 100% preventable disease. The Eurogin Conference is a prestigious global event convening top scientific minds in HPV detection, prevention, and treatment. By presenting its pivotal SELF-CERV study at this influential forum, Teal Health is contributing to the international conversation on cervical cancer eradication and advocating for expanded access to life-saving screening technologies. "With these results, we are one step closer to offering US women a scientifically validated, at-home cervical cancer screening option which is currently undergoing rigorous FDA review," said Kara Egan, CEO & Co-founder of Teal Health. "We believe this innovation has the power to transform preventive care, eliminate unnecessary barriers, and ultimately save lives." For more information about Teal Health visit About Teal Health Teal Health is on a mission to design a better healthcare experience for women - starting with cervical cancer screenings. By creating the option for a woman to screen for cervical cancer from the comfort of home and providing telehealth follow-up, Teal can increase access to this life-saving cancer screening. Teal Health is a member of the Cervical Cancer Roundtable, a joint collaboration between the American Cancer Society and the Biden Cancer Moonshot, a coalition of industry leaders with the goal of eliminating cervical cancer as a public health concern in the US. To learn more, visit View original content to download multimedia: SOURCE Teal Health Sign in to access your portfolio
