In the last five years, the healthcare industry has seen an explosion of data, reflecting not just a patient’s healthcare encounters, but also novel data sources such as genomic and biomarker data. These datasets can provide a wealth of clinical and scientific information, but their siloed nature has made it difficult for data users to determine which datasets are most appropriate for their unique enterprise needs. Healthcare and life sciences user demand for this type of fit-for-purpose data requires a technology solution at scale.

“We’re thrilled to be expanding our relationship with AWS in pursuit of providing our customers with a secure and scalable solution for leveraging healthcare data across the enterprise. We’ve heard from our customers that better data discovery and utilization will empower them to answer their most strategic questions across drug development, clinical research, and population health use cases,” said Kyle Armbrester, Datavant CEO.  

This strategic collaboration expands upon Datavant’s and AWS’ existing relationship, which created Datavant Connect tokenization technology as a compatible offering for AWS. With this SCA, Datavant will build additional capabilities leveraging AWS Clean Rooms – a service that helps companies collaborate with partners without sharing raw data – to provide a “no underlying data movement” solution for pre-sales feasibility analyses between data sources and data buyers.

With an initial focus on tools for data discovery and data partner assessment, the collaboration will accelerate the process of finding and evaluating fit-for-purpose datasets. This enables a more efficient and secure approach for healthcare data discovery, evaluation, and analytics.

“The majority of healthcare data today is still not being used to the fullest extent possible, due to strategic, privacy, and data wrangling challenges,” said Arnaub Chatterjee, Datavant President and GM of Life Sciences, Ecosystem, and Public Sector. “By delivering Datavant Connect capabilities directly where data resides, our customers will benefit from enhanced data security and faster time to insight.”

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CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today announced the expansion of its leadership team by welcoming four new executives. Hernan Lopez joins CND as Chief Operating Officer, Kathryn Van Wie as Vice President of Strategy & Business Development, Annemarie Benton as Vice President of Market Access, and Bryan May as Vice President of Information Technology.

“We are thrilled to welcome this outstanding group of world-class leaders to the CND executive team,” said Richard J. Morello, Chief Executive Officer of CND Life Sciences. “With their deep breadth of experience in healthcare, medical devices, life science, and biotech, we are well-positioned to expand our work helping physicians and patients detect and treat neurodegenerative diseases easier, safer, and more effectively than ever before.”

As Chief Operating Officer, Hernan Lopez will provide strategic leadership and drive operational excellence across a range of functional areas within CND. He has an unprecedented track record and nearly 20 years of experience in medical device and life sciences companies. Prior to joining CND, Hernan was the Executive Vice President of Operations at GT Medical Technology, where he successfully brought an innovative medical device for the treatment of brain cancer to market. Prior to GT Medical Technologies, Hernan successfully managed explosive growth venture-backed company operations with successful exits, supported post-merger integrations, and worked in several operations roles in contract manufacturing organizations as well as multinational medical device companies such as Boston Scientific.

Regarding his new appointment, Hernan Lopez remarked, “I am excited to join CND as a true pioneer in the field of neurodegenerative diseases. I look forward to collaborating with CND’s talented and dedicated team to advance our patient mission during this next phase of growth.”

Kathryn Van Wie, Vice President of Strategy & Business Development, will focus on key strategic initiatives including CND’s biomarker capabilities for pharmaceutical clinical trials, international market expansion, and growing partnerships leveraging complementary technologies. Kathryn is an attorney who spent a decade at Vertex Pharmaceuticals as Corporate Counsel and subsequently in US Marketing and as Chief of Staff in Commercial Strategy and Operations.

Annemarie Benton, Vice President of Market Access, will oversee the development and execution of CND’s market access and payer engagement strategies. Annemarie brings more than 17 years of experience in the life sciences and advanced diagnostic laboratory industries. She began her career as a molecular scientist and leverages her clinical background to advocate for the adoption of precision medicine solutions by navigating the evolving payer landscape. Prior to joining CND, Annemarie was Head of Managed Care at Bionano and led the payer relations and managed care department at Caris Life Sciences.

Bryan May, Vice President of Information Technology, will be responsible for all IT functions. With over 25 years of experience across diverse industries including healthcare, distribution, supply chain, and contract manufacturing, Bryan brings a proven track record of driving digital transformation, optimizing IT infrastructure, and implementing solutions to enhance operational efficiency and strategic growth. Prior to joining CND, Bryan worked at Atara Biotherapeutics where he supported infrastructure and cloud services across 3 sites. Before that, he served as the Senior Director of Infrastructure Services and Cloud Engineering at McKesson for 15 years.

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Proscia^®, a global leader in AI-enabled pathology solutions for precision medicine, has partnered with Nucleai, a leading spatial AI biomarker company that maps protein expression and cellular interactions within tissue samples to predict therapeutic outcomes. At the center of the collaboration, the companies will integrate Nucleai’s predictive biomarker solutions into Proscia’s Concentriq^® software platform and make them available as part of Proscia’s precision medicine AI portfolio to better inform patient care.

The rise of precision medicine is putting new pressures on diagnostic laboratories to tap into their pathology data, as whole slide images are among the best representations of disease. Nucleai’s predictive biomarkers create an AI-guided spatial map of a patient biopsy that helps these laboratories to target recruitment and optimize execution for the clinical trials they support. The same spatial mapping will also enable Nucleai’s applications to serve as companion diagnostics that match patients to the most effective treatment. Nucleai’s high-quality, scalable AI spatial and digital pathology solutions are adopted by over 60 percent of the top 20 biopharma companies in the world.

“Today’s advanced therapies require advanced diagnostics,” said David West, Proscia’s CEO. “Software-based approaches, made possible by the proliferation of pathology imaging and AI capabilities, offer a radical new option for bringing these treatments to patients. By expanding our AI pipeline with Nucleai’s solutions, we will elevate the role of the diagnostic laboratory in precision medicine to benefit drug developers, pathologists, and patients alike.”

Proscia’s Concentriq is an enterprise pathology platform for all digital pathology data and AI-enabled workflows from discovery to diagnosis. With a growing portfolio of applications from Proscia, Proscia’s customers, and leading third parties, it is addressing the widest range of AI use cases on a single platform. Concentriq is used by 14 of the top 20 pharmaceutical companies and major diagnostic laboratories worldwide.

“Together, Proscia and Nucleai will enable more pathologists and clinicians to convert the complex data from patient biopsies into precise, actionable insights that can drive better clinical trial and diagnostic decisions,” said Avi Veidman, Nucleai’s CEO. “Our partnership holds tremendous promise for advancing next-generation treatment modalities like ADCs, multispecifics, immunotherapy, and combination therapies. With the recent deployment of our technology to aid patient enrollment for an active trial and the growing need for AI-powered biomarkers across trials and diagnostics, this partnership represents a significant step forward in deploying our solutions, at scale. Together with Proscia, we can fundamentally improve the efficiency and effectiveness of introducing groundbreaking treatments and advancing patient care.”

Along with today’s news, Nucleai joins the Proscia Ready partner alliance. Proscia Ready is made up of solution providers helping diagnostic laboratories and life sciences organizations accelerate the scaled adoption of digital pathology with confidence through a comprehensive approach.

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Nucleai, a spatial AI biomarker company that deciphers cellular conversations and maps cellular interactions within tissue samples to predict therapeutic outcomes, announced today the expansion of its executive leadership team with the appointment of Vikas Ahuja as Vice President of Strategic Partnerships. With over 20 years of experience in life sciences, Ahuja will be responsible for building an ecosystem of partners—including diagnostic companies, contract research organizations (CROs), assay and instrument vendors, and software companies—that will enable Nucleai’s AI platform to be deployed at scale for late-stage clinical trials and diagnostic applications.

“Vikas has a wealth of experience and knowledge in business development across various sectors within the life sciences industry and is a perfect addition to our team,” said Avi Veidman, CEO of Nucleai. “Our AI spatial technology is currently used in an active clinical trial to aid patient selection. We’re seeing an increasing need for AI spatial biomarkers to support the rapidly growing pipeline of next-generation treatments, including antibody-drug conjugates, multi-specifics, and novel checkpoint inhibitors. Vikas’ proven track record of fostering strategic alliances and driving global growth initiatives speaks volumes about his expertise in building partnerships to scale the deployment of novel diagnostics. We are thrilled to welcome him to Nucleai, where his insights and leadership will accompany our mission to power the next generation of precision therapeutics with AI-driven spatial biomarkers and diagnostics.”

Before joining Nucleai, Ahuja held a leadership role as Vice President of Business Development & Strategy at Ambry Genetics, where he spearheaded corporate strategy, M&A activities, and licensing initiatives, and oversaw International business segments. He also led the establishment of international partnerships, strategically forging alliances across regions like Latin America, the Middle East, Southeast Asia, China, and Australia at Mallinckrodt Pharmaceuticals.

“This role presents a tremendous opportunity to leverage my experience in building impactful collaborations across the life sciences sector,” said Ahuja. “The recent partnership with GoPath Diagnostics is a prime example of how strategic alliances can advance our mission of transforming patient care through advanced AI-driven spatial biomarkers. I look forward to fostering similar partnerships to enhance our relationships with large commercial and diagnostic companies, propelling our innovative platform to new heights and ultimately improving patient outcomes.”

Ahuja earned his MBA from The Wharton School of the University of Pennsylvania and his MS in Chemical Engineering from Imperial College, London.

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Fountain Life, an advanced diagnostics, longevity and preventative health company, today announced Fountain Life CORE, its new membership package that provides an entry point to longevity and proactive health optimization for millions of Americans.

Fountain Life is committed to enhancing and preserving each member’s quality of life throughout the aging process by identifying potential issues before they become serious health concerns. The company is creating a new kind of predictive, preventive, personalized, and data-driven healthcare. By leveraging informed AI technologies and advanced diagnostic testing to identify conditions such as cancer, cardiac, metabolic, and neurodegenerative disease at the earliest stages, Fountain Life empowers individuals to live a longer, healthier, and optimized life. 

At $2995 per year, the Fountain Life CORE membership provides a pathway for new members to prioritize their health and get started on a proactive journey toward optimized health and longevity. CORE includes quarterly blood tests that analyze dozens of biomarkers, uncovering deep insights about a member’s cardiovascular health, metabolic health, hormonal balance, inflammatory response, and nutrition levels. Each test is followed by a televisit review with a Fountain Life longevity physician who creates a customized optimization plan based on the member’s biomarker results, lifestyle, environment, and genetic factors. Between physician visits, CORE members work with a Fountain Life certified health coach to achieve the goals laid out in the customized health plan. Fountain Life’s approach is rooted in the principles of functional medicine, which includes a balance of treating symptoms while also uncovering the underlying root cause of health issues.

“Fountain Life is fundamentally changing the approach to health and longevity. We recognize that traditional primary care physicians often fall short in fully assessing health diagnostics to optimize well-being and promote longevity and typically don’t employ the root cause, functional medicine approach. With our new CORE membership, we’re opening doors to proactive health for everyone while also extending our focus on longevity. This initiative embodies our commitment to equip everyone with the resources needed for proactive health management and longevity promotion, including access to some of the most advanced diagnostic tools available.” William Kapp, MD, CEO & Co-Founder, Fountain Life.

The Fountain Life CORE membership is easily and conveniently managed through an exclusive Fountain Life mobile app experience.  Members can schedule blood draws and appointments with Fountain Life physicians and health coaches, monitor their test results and progress over time, and access a comprehensive library of longevity and health-related content.  In addition, a CORE membership grants individuals access to additional a la carte diagnostic testing to detect asymptomatic cardiac disease, cancer, neurodegenerative disease and metabolic dysfunction.  Fountain Life centers offer some of the most advanced health diagnostics available today, including AI-enhanced Full-Body and Brain MRI and Coronary CT Angiography.

To learn more about Fountain Life’s new CORE Membership, please head to fountainlife.com/core-membership  

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Progress Continues on Original Collaboration to Develop a MeMed BV-Based Assay for use on Beckman Coulter Immunoassay Analyzers

Beckman Coulter Diagnostics, a global leader in clinical diagnostics, and MeMed, a leader in the emerging field of advanced host-response technologies, today announced expansion of their host immune response diagnostics partnership. Beckman Coulter is now an authorized distributor of the MeMed BV® assay, a rapid immunoassay test able to distinguish between bacterial and viral infections, and MeMed Key®, a compact immunoassay analyzer cleared to run the MeMed BV assay in the United States and Europe. This new distribution agreement complements the existing joint effort to develop a MeMed BV-based test for Beckman Coulter’s family of Access Immunoassay Analyzers.

Symptoms of bacterial and viral infections are often clinically indistinguishable, which creates challenges for physicians when deciding to start treating patients with antibiotics or not. Unfortunately, this ambiguity can result in the underuse and overuse of antibiotics. Recent research published in Biomedicines showed that up to 29% of the time, clinicians face uncertainty in differentiating bacterial versus viral infections, which can cause delays in clinical decision-making and inefficient diagnostic workflows. This research report indicated that the MeMed BV assay supported or altered physician decision-making in 87% of cases (p < 0.05). MeMed BV returns results in 15 minutes from serum or whole blood and has >99% negative predictive value (NPV)* to rule out bacterial infection. ^1-3

“Beckman Coulter’s commitment to improving infection management is unwavering,” said Kevin O’Reilly, President, Beckman Coulter. “To that end, we are excited to extend our partnership with MeMed by expanding market access to the MeMed Key and BV assay. These MeMed innovations complement Beckman Coulter’s portfolio of host response diagnostics, including our CBC-based hematological biomarker MDW [monocyte distribution width] identifying the presence of severe infection and risk of sepsis, our clinical chemistry PCT [procalcitonin] assay aiding risk assessment for septic shock, and our full suite of microbiology solutions providing faster time to optimize antibiotic therapies.”

Dr. Eran Eden, MeMed’s CEO and co-founder, added: “We’re excited to expand our partnership with Beckman Coulter, taking an additional step forward in our shared mission to advance pioneering host-response solutions. This expansion focuses on two main objectives: first, to educate and prime the market to accelerate the adoption of MeMed BV once it’s cleared for use on Beckman Coulter’s core-lab immunoassay analyzers; second, to broaden patient access to MeMed BV through a strategic hub and spoke model. By combining the capabilities of Beckman Coulter’s analyzers with the MeMed Key’s ability to deliver results directly from whole blood within minutes, we’re creating a synergistic ecosystem that aids clinicians in distinguishing between bacterial and viral infections with unprecedented ease and precision.” 

MeMed BV is a diagnostic test developed to address management of patients with acute infection in different clinical settings, including Emergency Departments. The MeMed BV test uses a machine learning-derived algorithm to integrate measurements of three key host-immune proteins (TRAIL, IP-10, and CRP) into a score indicating the likelihood of bacterial or viral infections. The performance has been validated on the MeMed Key by world class institutions in multi-national blinded validation studies as well as rapidly growing real-world use in the U.S. and EU, altogether in over 20,000 patients.^1-5 MeMed BV on MeMed Key is US FDA cleared, CE-Marked and approved by the Israeli Ministry of Health.

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Revolution Endpoints is already meticulously evaluating emerging technologies for adoption while exploring licensing, partnership, or acquisition of the most promising and synergetic opportunities. By identifying and integrating emerging technologies that complement internal development efforts and existing services, Imaging Endpoints intends to ensure it continues to lead the industry in service offerings.

Doug Dean Burkett, CEO and President of Imaging Endpoints commented: “For fifteen years we have been relentlessly executing on a consistent, unwavering strategy to organically grow our leadership in oncology-focused imaging CRO services. We are now generally recognized as leading the industry in science and quality, and our efforts have yielded remarkable growth.  We are fortunate to be in a position to invest in emerging technologies that are synergistic with our own development projects and our vision to Connect Imaging to the Cure. Through this new subsidiary, we are excited to explore new frontiers, support transformative ideas, and continue our mission of advancing healthcare and improving patient outcomes.”

IE believes in the power of collaboration and innovation to drive progress in the fight against cancer. Revolution Endpoints is engaging with emerging technology leaders within AI assisted image evaluation, quantitative biomarkers, big datasets, predictive analytics and NLP, 3D imaging, AR, VR, AI enhanced enterprise automation, and blockchain technology that have potential to further streamline and improve both image workflows and efficacy analysis. Service providers with synergistic technologies and service offerings may also be of interest.

For more information about Revolution Endpoints or to discuss your emerging technology with our experts, please visit Revolution Endpoints or contact us at more@revolutionendpoints.com. 

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This partnership unites Nucleai and GoPath’s complementary skills to expedite the development of new AI-powered clinical research and diagnostics. The integrated solutions will be deployed within a centralized environment that meets the standards of the College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA), Clinical Laboratory Evaluation Program (CLEP), Good Clinical Practice (GCP), and Good Clinical Laboratory Practice (GCLP). This will support clinicians and biopharma partners throughout all stages of oncology and immunology drug development.

Key highlights of the collaboration include:

• Systems Integration: Nucleai will integrate its suite of AI algorithms and digital pathology viewer with GoPath’s Laboratory Information Management Systems (LIMS) and Laboratory Management Systems (LMS) for real-time sharing of data, at scale, to enable centralized, on-demand AI analysis to augment clinicians’ review of diagnostic pathology cases.
• Joint Research Initiatives: Nucleai and GoPath will collaborate on a series of research projects aimed at exploring new predictive AI algorithms to derive actionable insights across multiple oncology and immunology indications, such as prostate cancer and inflammatory bowel disease (IBD).
• BioPharma Partner Support: The collaboration will empower new and ongoing collaborations with sponsored clinical trials through centralized access to real-world training and validation datasets, comprehensive molecular and pathology services, and advanced AI capabilities.

Avi Veidman, CEO of Nucleai, said: “The use of AI spatial biomarkers to make treatment decisions is inevitable, and it’s not a question of if but when. As pioneers in this field, Nucleai is making sure that AI spatial biomarkers are actionable sooner than people think. The partnership with GoPath is a critical step in realizing this vision by complementing our AI spatial capabilities with their digital pathology expertise so we can deploy AI spatial biomarkers into clinical and diagnostic use for broader adoption.”

Jim Lu, M.D., CEO and Medical Director for GoPath Diagnostics, said: “Our collaboration with Nucleai transforms our capabilities, enabling GoPath to deliver a seamlessly integrated lab workflow. This workflow is fully digital, spanning from initial digitization to an intuitive viewing platform, powered by advanced AI algorithms for efficient case management and sign-out processes. By incorporating Nucleai’s innovative AI technology, we’re significantly enhancing diagnostic accuracy and the efficacy of treatment strategies within the healthcare sector. Our united efforts mark a leap forward in propelling clinical research, the biopharmaceutical industry, and the field of precision medicine into a new era.”

The strategic collaboration between Nucleai and GoPath begins immediately with an initial focus on AI-powered pathology analysis at scale to deliver clinically actionable insights across multiple clinical trials and research initiatives.

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As part of the agreement, Ambry is performing germline sequencing assays for Tempus, powered by Ambry’s CancerNext^® and CancerNext-Expanded^® assays. Utilizing next-generation sequencing, the assays identify genetic variants associated with hereditary cancer syndromes and inherited risk of cancer, and leverages Ambry’s 25-year history of variant interpretation expertise.

Tempus’ xG and xG+ germline assays are a part of Tempus’ extensive portfolio of oncology-focused testing solutions that maximize biomarker detection and identify actionable variants linked to targeted therapy and clinical trial options. Tempus offers a comprehensive collection of genomic profiling solutions of solid tumor and liquid biopsy, along with algorithmic-based tests such as HRD and TO (tumor of unknown origin). These tools are designed to help physicians optimize patient care by providing clinically actionable data that can inform decisions throughout the treatment journey.

“Our collaboration with Tempus will provide an invaluable resource for patients and physicians because it leverages our respective expertise,” said Brigette Tippin Davis, Ph.D., Chief Operating Officer of Ambry Genetics. “Tempus has a powerful offering for tissue and liquid biopsy DNA and RNA profiling and somatic testing. Now, with our germline testing and variant assessment expertise behind Tempus xG and xG+, we are poised to create a future where paired somatic and germline testing is the standard. We believe this will drive precision oncology, proactive healthcare for those patients at hereditary risk, and insights that may affect generations.”

“We aim to be a one-stop-shop for clinicians as they navigate each patient’s treatment path, and germline testing is a critical element in diagnosing and treating patients that may have existing hereditary mutations,” said Mike Yasiejko, Executive Vice President and General Manager, Genomics at Tempus. “Ambry has extensive experience in germline genetic testing, and we look forward to working together to enhance our molecular profiling offerings.”

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Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications that assist in diagnosing cancer, today announced a significant expansion of its AppLab marketplace, with the addition of six new digital pathology and AI providers. New applications from these industry-leading companies, including Imagene, Histofy, Aiosyn, Clinsight, DoMore Diagnostics, and Stratipath*, will be added to the AppLab to provide support for pathology labs worldwide in building deeply integrated and customized AI-enabled workflows.

The Paige AppLab is a comprehensive marketplace where, within a few clicks, pathologists can seamlessly browse, trial, and purchase a robust set of diagnostic support tools from various providers that can be then accessed in the Paige Platform and FullFocus^® viewer to support each unique step of cancer diagnosis. The AppLab delivers full vendor-neutrality and flexibility to ensure labs are equipped with all the insights they need—from Paige or other partners—to efficiently meet the unique needs of their patients, now and in the future.

The newly introduced applications unlock advanced AI-powered capabilities such as biomarker detection from H&E-stained slides, assistance with the grading and assessment of cancer across tissue types, risk-stratification, and more. Paige has worked closely with each AppLab vendor to ensure their technology is seamlessly integrated into the Paige Platform to simplify AI adoption and propel the practice of digital pathology forward.

“We are excited to be part of Paige’s AppLab which ensures seamless and easy integration of AI solutions for end users. This is critical to bring innovation in the field forward,” said Torbjørn Furuseth, Co-Founder and CEO of DoMore Diagnostics. “Paige will be a key partner as we continue to push the boundaries to personalize cancer treatment with our Histotype Px digital biomarkers.”

Nasir Rajpoot, Co-Founder and Chief Scientific Officer of Histofy, added, “Paige AppLab allows Histofy a very exciting route for putting our groundbreaking AI solutions in the hands of a rapidly increasing number of pathologists and researchers using the Paige Platform. We are excited at the prospect of delivering our AI tools to market through Paige.”

Designed for real-world clinical utilization, Paige is committed to arming pathologists with the highest-quality products. Each new application can be trusted to work alongside Paige tools and applications to offer one powerful guidance engine that truly unlocks the full potential of digital pathology and AI.

“We are excited to welcome these six additional industry-leading digital pathology vendors to the Paige AppLab. Their partnership serves as a testament to the innovative and cutting-edge technology Paige is built upon,” said Jill Sue, Vice President of Product, Paige. “With these vendor additions, the Paige AppLab serves as the one-stop-shop for all digital pathology needs.”

If you are interested in accessing the AppLab, have an application you’d like to add to the marketplace or are using an application you wish to see made available in your workflow, request a demo to be directly connected with a member of the Paige team.

*Stratipath breast is CE-IVD marked for clinical use

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