# Clinical Validation * **Definition:** The process of confirming the effectiveness and safety of a medical device, treatment, or diagnostic test through scientific studies, real patient data, and clinical trials to ensure it performs as intended in a clinical setting. * **Taxonomy:** Healthcare Topics / Clinical Validation ## News * Selected news on the topic of **Clinical Validation**, for healthcare technology leaders * 1.8K news items are in the system for this topic * Posts have been filtered for tech and healthcare-related keywords | Date | Title | Source | | --- | --- | --- | | 5/28/2025 | [**Critical Role of Transitions of Care in Medicare Advantage Success - HIT Consultant**](https://hitconsultant.net/2025/05/28/critical-role-of-transitions-of-care-in-medicare-advantage-success/) | [[HIT Consultant]] | | 5/28/2025 | [**Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™ Test and ...**](https://finance.yahoo.com/news/exact-sciences-announces-expanded-clinical-100500144.html) | [[Yahoo Finance]] | | 5/13/2025 | [**Complement 1 Secures $16M for Clinically Validated Cancer Lifestyle Modification Platform**](https://hitconsultant.net/2025/05/13/complement-1-secures-16m-for-clinically-validated-cancer-lifestyle-modification-platform/) | [[HIT Consultant]] | | 5/8/2025 | [**Reflecting On Medical Devices & Supplies - Diversified Stocks' Q1 Earnings - Yahoo Finance**](https://finance.yahoo.com/news/reflecting-medical-devices-supplies-diversified-033149641.html) | [[Yahoo Finance]] | | 5/8/2025 | [**NextGen Jane Awarded Second NIH Grant For The Evaluation of a Non-Invasive ... - PR Newswire**](https://www.prnewswire.com/news-releases/nextgen-jane-awarded-second-nih-grant-for-the-evaluation-of-a-non-invasive-endometriosis-diagnostic-302449231.html) | [[PR Newswire]] | | 4/25/2025 | [**Global Virtual Care Market to Surge: From $7.9 Billion in 2023 to $24.1 Billion by 2030 at a ...**](https://finance.yahoo.com/news/global-virtual-care-market-surge-141500480.html) | [[Yahoo Finance]] | | 4/3/2025 | [**Circulating Tumor Cell (CTC) Market Analysis and Forecast 2025-2030 - Yahoo Finance**](https://finance.yahoo.com/news/circulating-tumor-cell-ctc-market-110400613.html) | [[Yahoo Finance]] | | 4/1/2025 | [**AI-Powered Medical Diagnostics Decision Support Devices Global Startup Deep Dive ...**](https://medium.com/@alexglee/ai-powered-medical-diagnostics-decision-support-devices-global-startup-deep-dive-analysis-q1-2025-494fe36c8175) | [[Medium]] | | 3/30/2025 | [**AI-Powered Medical Diagnostics Decision Support Devices Global Startup Deep Dive ...**](https://www.linkedin.com/pulse/ai-powered-medical-diagnostics-decision-support-deep-alex-g--q6rce) | [[Linkedin]] | | 2/14/2025 | [**Engineering a Healthcare Analytics Center of Excellence (ACoE): A Strategic Framework for ...**](https://blogs.perficient.com/2025/02/14/engineering-a-healthcare-analytics-center-of-excellence-acoe-a-strategic-framework-for-innovation/) | [[Perficient Healthcare]] | | 12/13/2024 | [**Title: Navigating the Generative AI Journey: A Strategic Roadmap for Healthcare Organizations**](https://blogs.perficient.com/2024/12/13/title-navigating-the-generative-ai-journey-a-strategic-roadmap-for-healthcare-organizations/) | [[Perficient Healthcare]] | | 12/9/2024 | [**Responding to denials with CDI data s - 3 key takeaways**](https://www.beckershospitalreview.com/finance/responding-to-denials-with-cdi-data-analytics-3-key-takeaways.html) | [[Beckers Hospital Review]] | | 12/2/2024 | [**Clinical Validation Study on Natera's Fetal RhD NIPT Published in Obstetrics & Gynecology**](http://www.businesswire.com/news/home/20241202602532/en/Clinical-Validation-Study-on-Natera%E2%80%99s-Fetal-RhD-NIPT-Published-in-Obstetrics-Gynecology/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 12/1/2024 | [**Clinical Validation Study on Natera's Fetal RhD NIPT Published in Obstetrics gy**](https://www.morningstar.com/news/business-wire/20241202602532/clinical-validation-study-on-nateras-fetal-rhd-nipt-published-in-obstetrics-gynecology) | [[Morningstar]] | | 11/29/2024 | [**Click Therapeutics Launches Software-Enhanced Drug Therapies**](https://thehealthcaretechnologyreport.com/click-therapeutics-launches-software-enhanced-drug-therapies/) | [[Healthcare Technology Report]] | | 11/10/2024 | [**The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know**](https://medcitynews.com/2024/11/the-trust-building-playbook-5-tips-every-digital-health-marketer-needs-to-know/) | [[MedCity News]] | | 8/30/2024 | [**Nearly Half of AI Health Tools Fall Short on Public Data - Medscape**](https://www.medscape.com/viewarticle/nearly-half-ai-health-tools-fall-short-public-data-2024a1000ftu) | [[Medscape]] | | 8/26/2024 | [**Almost half of FDA-approved AI medical devices are not trained on real patient data, research reveals**](https://medicalxpress.com/news/2024-08-fda-ai-medical-devices-real.html) | [[MedicalXpress]] | | 8/26/2024 | [**Almost half of FDA-approved medical AI devices lack clinical validation data**](https://www.news-medical.net/news/20240826/Almost-half-Of-FDA-approved-medical-AI-devices-lack-clinical-validation-data.aspx) | [[News Medical Net]] | | 7/16/2024 | [**Ethical Considerations in the Use of Artificial Intelligence and Machine Learning in Health Care**](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11249277/) | [[NCBI - NIH]] | | 7/10/2024 | [**Tempus Surpasses 500 Research Publications**](http://www.businesswire.com/news/home/20240710634642/en/Tempus-Surpasses-500-Research-Publications/?feedref=JjAwJuNHiystnCoBq_hl-Q-tiwWZwkcswR1UZtV7eGe24xL9TZOyQUMS3J72mJlQ7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LOzmn6JePCpHPCiYGaEx4DL1Rq8pNwkf3AarimpDzQGuQ==) | [[Business Wire]] | | 7/10/2024 | [**Tempus Surpasses 500 Research Publications**](http://www.businesswire.com/news/home/20240710634642/en/Tempus-Surpasses-500-Research-Publications/?feedref=JjAwJuNHiystnCoBq_hl-RLXHJgazfQJNuOVHefdHP-D8R-QU5o2AvY8bhI9uvWSD8DYIYv4TIC1g1u0AKcacnnViVjtb72bOP4-4nHK5ieT3WxPE8m_kWI77F87CseT) | [[Business Wire]] | | 7/9/2024 | [**Reining In the Wild West of AI - MedCity News**](https://medcitynews.com/2024/07/reining-in-the-wild-west-of-ai/) | [[MedCity News]] | | 6/3/2024 | [**Compliantly supercharge your hospitals bottom line**](https://www.healthcaredive.com/spons/compliantly-supercharge-your-hospitals-bottom-line/717430/) | [[Healthcare Dive]] | | 2/14/2023 | [**Preventing and Defending: 2 Keys to Reducing Clinical Validation Denials in the Revenue Cycle**](https://www.healthleadersmedia.com/revenue-cycle/preventing-and-defending-2-keys-reducing-clinical-validation-denials-revenue-cycle) | [[HealthLeaders Media]] | ## Topic Overview (Some LLM-derived content — please confirm with above primary sources) ### Key Players - **CorroHealth**: A healthcare technology company that developed the VISION Clinical Validation Technology™ to enhance Clinical Documentation Integrity (CDI) processes. - **Proteotype Diagnostics**: Collaborating with the University of Southampton to validate the Enlighten™ Multi-Cancer Early Detection test. - **PointClickCare**: A healthcare technology company focusing on AI solutions that prioritize trustworthiness and clinical validation through rigorous testing and real-world data. - **GRAIL, Inc.**: A company conducting large-scale studies for early cancer detection tests, focusing on clinical validation and regulatory approval. - **ROSE Diagnostics**: A company developing the verifi LUNG Test for lung cancer diagnostics, focusing on clinical validation. - **Median Technologies**: A company that developed the eyonis LCS for lung cancer screening, which has successfully completed clinical validation. - **PreciseDx**: A company utilizing AI for breast cancer risk assessment, enhancing clinical validation and commercialization. - **Immunovia**: A company developing tests for early detection of pancreatic cancer, currently pursuing clinical validation. - **Nationwide Children's Hospital**: Researchers identified a potential biomarker in maternal blood for early detection of single ventricle heart diseases, requiring clinical validation. - **OncoAssure Ltd**: An Irish medical diagnostic company that has demonstrated clinical validation of its prostate cancer biopsy test, enhancing treatment selection. - **Telo Genomics Corp.**: A company conducting clinical validation studies for its minimal residual disease biomarker assay technologies. - **Oregon Health & Science University**: Researchers who developed the PAC-MANN assay for early detection of pancreatic cancer, showcasing significant clinical validation. - **Exact Sciences**: A company involved in developing the Oncodetect test for colon cancer, which has shown promising clinical validation results. - **BrainTale**: Developed a biomarker for predicting the progression of X-linked adrenoleukodystrophy (X-ALD), with ongoing clinical validation efforts. - **Dandelion Health**: A startup that has launched a clinical AI marketplace to enhance clinical trials through validated algorithms. - **Mobilise-D**: A consortium focused on integrating validated Digital Mobility Outcomes into clinical trials and healthcare assessments. - **Tempus AI, Inc.**: A company focused on AI and precision medicine, known for its extensive research and collaborations in clinical validation. - **Neurotech Companies**: Organizations developing technologies aimed at enhancing mental health and cognitive function, emphasizing the need for clinical validation. - **eyonis™ LCS**: An AI-powered diagnostic device for lung cancer detection, undergoing clinical validation through the RELIVE trial. - **BrainCheck, Inc.**: A company that developed BrainCheck Assess, a cognitive assessment tool validated against MoCA. ### Partnerships and Collaborations - **BrainTale and Clinical Centers**: Conducting the CALDIFF study to validate a biomarker for X-ALD across multiple centers. - **Proteotype Diagnostics and University of Southampton**: Joint effort to validate the Enlighten™ Multi-Cancer Early Detection test. - **Proteotype Diagnostics Ltd**: In partnership with the University of Southampton to validate their multi-cancer early detection test. - **Lucid Diagnostics and Dr. Nicholas J. Shaheen**: Collaboration on the EsoGuard BE-1 study for clinical validation of the EsoGuard test. - **Immunovia**: Plans to conduct a large independent clinical validation study for its pancreatic cancer test. - **Nationwide Children's Hospital and Research Institutions**: Working on the clinical validation of a biomarker for early detection of congenital heart diseases. - **Telo Genomics and McGill University**: Collaboration for clinical validation of MRD biomarker assay technologies. - **Tempus AI, Inc.**: Collaborates with biopharma and academic partners to validate its diagnostic offerings through extensive research. - **ProPhase Labs and Forward Healthcare Consultants**: Partnership to commercialize the BE-Smart test focusing on clinical validation and market access. - **IMD and Cedars-Sinai**: IMD collaborates with Cedars-Sinai Molecular Lab on a next-generation sequencing cancer panel for solid tumors, which is set for clinical validation. - **Koneksa and Regeneron**: Collaboration in the LEARNS observational study to validate digital biomarkers for Parkinson's disease. - **Exact Sciences and National Surgical Adjuvant Breast and Bowel Project**: Collaboration to generate additional clinical evidence for the Oncodetect test across multiple solid tumor types. - **Quibim**: A company focused on integrating AI-powered imaging biomarkers into clinical practice, emphasizing the need for clinical validation in regulated medical devices. - **Empatica and Mobilise-D**: Collaborated to integrate validated Digital Mobility Outcomes into Empatica's Health Monitoring Platform, improving clinical care and research. - **Biotia and Medical Institutions**: Collaborating to integrate the BIOTIA-ID test into clinical workflows to enhance accessibility for patients. - **NJ Bio and Charles River Laboratories**: A strategic alliance to enhance the development and manufacturing of antibody drug conjugates, focusing on clinical validation and safety. - **Veravas and Phanes Biotech**: Co-developing a blood-based assay for Alzheimer's disease, focusing on tau pathology detection. - **Clario and Mobilise-D**: Partnered to integrate digital mobility outcomes with Clario's Opal wearable sensor system to enhance patient mobility data capture in clinical trials. - **Curi Bio and Novoheart**: Collaboration to integrate cardiac organoid technology into data analysis platforms for drug development. ### Innovations, Trends, and Initiatives - **Clinical Validation Framework**: A proprietary evaluation model assessing clinical relevance, technical performance, and regulatory compliance for AI-powered diagnostics. - **Clinical Validation Studies**: Ongoing trials and studies aimed at validating new diagnostic tests and devices across various cancer types. - **Clinical Validation of AI Tools**: The healthcare industry is emphasizing the need for robust clinical validation of AI-driven medical devices to ensure effectiveness and safety. - **AI in Clinical Validation**: The integration of AI and machine learning in healthcare is transforming clinical workflows, but it necessitates rigorous clinical validation to ensure safety and effectiveness. - **Neurotechnology Advancements**: Recent innovations in neurotechnology highlight the importance of clinical validation for user adoption and trust. - **AI in Healthcare**: Increasing integration of AI technologies in clinical settings, with a focus on clinical validation. - **Emerging Diagnostic Tests**: Innovative tests like the BIOTIA-ID and the pancreatic cancer blood test are undergoing clinical validation to improve diagnostic accuracy and patient outcomes. - **AI-Powered Diagnostic Tools**: Avicenna.AI's algorithms have received certifications, reflecting advancements in AI diagnostics and their clinical validation. - **Regulatory Changes for LDTs**: Upcoming stricter requirements for the analytical and clinical validation of laboratory-developed tests (LDTs) are expected to impact development timelines. - **PAC-MANN Assay**: A non-invasive test for early-stage pancreatic cancer detection, showing high sensitivity and specificity in clinical validation. - **Digital Mobility Outcomes**: The trend towards integrating validated digital measures into clinical trials is gaining momentum, with a focus on improving patient mobility assessments. - **Complement 1**: Launching a clinically validated lifestyle modification platform for cancer care, integrating AI-driven personalization. - **Mental Health Apps Market**: Projected growth driven by increased demand for accessible mental health solutions, highlighting the need for standardized clinical validation. - **Clinical Documentation Integrity (CDI)**: Evolving from a cost center to a strategic asset, CDI programs are increasingly utilizing AI to enhance documentation accuracy and compliance. - **Digital Biomarkers**: Utilization of digital biomarkers in clinical trials to enhance disease monitoring and therapeutic development. - **AI for IMPACTS Framework**: A proposed framework to assess the translational readiness of AI in healthcare, addressing gaps in current evaluation methods. ### Challenges and Concerns - **Need for Clinical Validation**: Many emerging diagnostic tools and biomarkers require robust clinical validation to ensure their effectiveness and safety before widespread adoption. - **Clinical Validation Gaps**: A significant percentage of FDA-authorized AI health devices lack publicly available clinical validation data. - **Validation of AI Algorithms**: Challenges in validating AI algorithms in healthcare, with no single health system capable of performing adequate validations. - **AI Medical Devices**: Concerns about the effectiveness of AI medical devices that have not been trained on actual patient data, highlighting the need for thorough clinical validation. - **Regulatory Challenges**: The FDA is addressing concerns over AI devices lacking real-world patient data validation, emphasizing the need for rigorous clinical validation. - **Trust and Validation in AI**: Concerns regarding the establishment of trust in AI systems and the need for rigorous clinical evidence to support their integration into healthcare. - **Lack of Clinical Validation**: Nearly half of AI medical devices approved by the FDA lack reported clinical validation data, raising concerns about their effectiveness and safety. - **Regulatory Hurdles**: Challenges in navigating the regulatory landscape for new diagnostic and therapeutic technologies, impacting clinical validation timelines. - **Trust and Transparency**: The need for AI models to be transparent and rigorously tested to gain clinician trust and ensure effective adoption in clinical settings. - **Bias in AI**: There are ongoing concerns regarding biases in AI algorithms, necessitating rigorous clinical validation to ensure equitable healthcare outcomes. - **Ethical Oversight in Clinical Trials**: The complexity of validating neural prostheses raises ethical considerations and the need for comprehensive oversight in clinical trials. - **Data Privacy and Cybersecurity**: Growing concerns as nearly half of FDA-authorized AI devices lack sufficient validation, prompting calls for improved safety reporting frameworks. - **Workforce Crisis**: The U.S. healthcare system faces a significant workforce shortage, which may impact the implementation and validation of new technologies. - **Ethical Considerations**: Addressing patient data privacy and potential biases in AI implementations to ensure equitable healthcare outcomes. - **Healthcare Inequities**: Current diagnostic methods may contribute to healthcare inequities, highlighting the need for earlier and more accessible detection methods. - **Regulatory Compliance**: Navigating the complexities of regulatory approvals and compliance for AI technologies in healthcare.