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Associated Press
4 days ago
- Business
- Associated Press
Hologic Joins NEST Governance Committee to Advance the Use of Real-World Data in Medical Device Evaluation
ARLINGTON, Va.--(BUSINESS WIRE)--Jun 2, 2025-- The National Evaluation System for health Technology (NEST), an initiative of the Medical Device Innovation Consortium (MDIC), is pleased to welcome Hologic, a leading global medical device and diagnostic company, to its Governance Committee. This appointment reflects Hologic's commitment to advancing the use of real-world data (RWD) to support medical device evaluation and drive innovation in women's health. Hologic is the latest partner to join the NEST Governance Committee which convenes a diverse group of leaders from across the medical device ecosystem—including regulatory agencies, industry, academia, patient organizations, and health systems. NEST's mission aims to accelerate patient access to life-changing innovation by supporting the sustainable generation and use of timely, reliable and cost-effective real-world evidence (RWE) solutions throughout the medical device total product lifecycle. To advance this mission, NEST's Governance Committee plays a pivotal role by jointly identifying and prioritizing key initiatives that drive RWE generation for medical devices in support of regulatory submission packages, all while ensuring a patient-centered, inclusive, accountable, and transparent approach. 'Hologic is honored to join the NEST Governance Committee and contribute to advancing the use of real-world evidence in diagnostic and medical device evaluation,' said Jeff Hergesheimer, Senior Director, Regulatory Affairs at Hologic and newly appointed NEST Governance Committee member. 'Real-world data plays a critical role in accelerating innovation and improving patient outcomes. Through collaboration with NEST and other stakeholders, we look forward to driving solutions that enhance regulatory decisionmaking and deliver impactful healthcare advancements.' Through NEST Governance Committee involvement, Hologic will help accelerate patient access to cutting-edge technologies, bring a unique perspective as an industry leader in women's health, and contribute to the evolution of RWE approaches in regulatory decision making. Through its contributions, Hologic brings a valuable perspective grounded in both technical expertise and an enduring commitment to innovation in women's health. 'We are thrilled to welcome Hologic and Jeff to the NEST Governance Committee,' said Simon Mason, president at NEST. 'Their pioneering leadership in women's health meets an untapped need on our committee coupled with their commitment to employing RWE in regulatory submissions will bring invaluable insights and experience and most importantly, improve patient care and quality of life.' For more information about Hologic, visit About Hologic, Inc. Hologic, Inc. is a global leader in women's health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit and connect with us on LinkedIn,Facebook,X,Instagram and YouTube. About NEST (National Evaluation System for health Technology) In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NEST). NEST is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients' access to safe and effective medical technology and provide Quality Evidence by Design™. For more information on NEST, please visit or connect with us on LinkedIn. About MDIC (Medical Device Innovation Consortium) At MDIC, we unite in a shared mission to improve health and save lives by accelerating access to medical technologies. Through stakeholder collaboration, MDIC leads the way in advancing the scientific and technical foundations of medical device design, manufacturing, regulation, reimbursement and clinical integration. Founded in 2012 as a nonprofit, public-private partnership to elevate regulatory science, MDIC develops new approaches and tools for addressing shared challenges among medical device manufacturers, researchers, regulators, payers, patients, and health care providers. We deliver high impact work in the core areas of quality design and manufacturing, evidence generation, digital technology and transformation, and patient engagement. To learn more and join us in our mission, visit View source version on CONTACT: Media Contacts: Bridget Perry Sr. Director of Communications [email protected] Victoria Vice President, Brand and Experience MDIC [email protected] Investor Contact: Michael Watts Corporate Vice President, Investor Relations [email protected] KEYWORD: VIRGINIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: OTHER HEALTH PROFESSIONAL SERVICES DATA MANAGEMENT TECHNOLOGY MEDICAL DEVICES HEALTH TECHNOLOGY DATA ANALYTICS SCIENCE MEDICAL SUPPLIES FDA OTHER TECHNOLOGY HEALTH OTHER SCIENCE SOURCE: Medical Device Innovation Consortium Copyright Business Wire 2025. PUB: 06/02/2025 11:03 AM/DISC: 06/02/2025 11:02 AM
National Post
14-05-2025
- Health
- National Post
Komodo Health's Real-World Evidence Platform Drives 31 Patient Journey Research Studies at ISPOR 2025
Article content Comprehensive Patient Journey Data Links Clinical Outcomes to Real-World Impact, Addressing Critical Evidence Gaps in Oncology, Neurology, Cardiovascular, Metabolic, and Rare Diseases Article content Article content MONTREAL — Komodo Health today announced that its healthcare intelligence platform enabled 31 research studies being presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) global conference. These include three studies led by Komodo researchers and 27 collaborative studies with academic institutions, Life Sciences companies, and healthcare organizations. Article content 'The volume and diversity of research powered by our healthcare insights underscore the growing demand for high-quality real-world data combined with advanced analytical capabilities,' said Arif Nathoo, MD, CEO and Co-Founder, Komodo Health. 'By connecting individual patient journeys to large-scale health outcomes, we're enabling researchers to uncover actionable insights that improve clinical practice, healthcare policy, and patient outcomes.' Article content The ISPOR 2025 research presentations demonstrate the value of Komodo's real-world evidence across a wide range of therapeutic areas, including: Article content Oncology: Salix Pharmaceuticals, Analysis Group, and Bausch Health studied the economic burden of opioid-induced constipation among patients with or without cancer; Cardiovascular disease: Veradigm examined the discordance between apolipoprotein B and low-density lipoprotein cholesterol levels in predicting incident hypertension risk and how it correlates to differential hypertension development patterns between diabetic and non-diabetic populations; Metabolic disorders: Novo Nordisk studied non-invasive diagnostic approaches and earlier interventions for metabolic dysfunction-associated steatohepatitis (MASH); Neurology: Jazz Pharmaceuticals analyzed healthcare resource utilization and costs among individuals with narcolepsy or idiopathic hypersomnia (IH) who are considered at higher risk for negative clinical outcomes associated with sodium (due to underlying cardiovascular, cardiometabolic, or renal conditions); and Rare disease: Chiesi analyzed medical claims data to better understand healthcare resource utilization patterns among Fabry disease patients Article content Three poster presentations by Komodo researchers also showcase methodological advances: Article content Komodo provides a multidimensional view of 330+ million patient journeys by linking de-identified claims data with specialty datasets, including lab results, genomics, and demographic information — through its platform to address fundamental challenges in health economics and outcomes research (HEOR). Whereas HEOR teams have traditionally relied on fragmented, incomplete datasets that provide only narrow snapshots of patients' in-network healthcare experiences, Komodo's platform enables researchers to link disparate datasets without the months typically spent on data cleaning and integration. The option to enhance disease understanding at the patient level with lab, EHR, patient insurance, race and ethnicity, and mortality data enables teams to self-serve cohort feasibility and insights. This ability accelerates study planning timelines by weeks and generates more accurate estimates of treatment patterns, healthcare resource utilization, and costs. Article content 'By closing critical data gaps and providing a patient-centric approach to HEOR, our powerful, all-in-one platform brings clean, connected, and compliant real-world data together,' Nathoo added. 'We eliminate the need for messy integrations, manual data wrangling, and coding cohorts from scratch, which enables HEOR teams to generate evidence faster. The inclusion of race, ethnicity, mortality, and other demographic insights at a near-census level also allows researchers to better model the clinical and financial impacts of new therapies across diverse populations, addressing the reality that disease burden is not borne equally across demographic groups.' Article content Article content Article content Article content Article content Contacts Article content Media Contacts: Rowena Kelley 858.255.1651 media@ Article content Article content Article content
