Editors: Raymond D. Aller, MD, & Dennis Winsten
FDA grants marketing authorization for product to detect and predict sepsis
May 2024—The FDA has granted marketing authorization, through the de novo pathway, for Prenosis’ Sepsis ImmunoScore artificial intelligence-enabled software as a medical device, or SaMD, for the rapid diagnosis and prediction of sepsis.
Leveraging a combination of biomarkers and clinical data through AI, Sepsis ImmunoScore helps determine risk for the presence or progression of sepsis within 24 hours of a patient being assessed in the emergency department or other areas of the hospital. The functionality is integrated in the hospital’s electronic medical record.
The software uses 22 parameters, including cell counts, temperature, and heart rate, to evaluate a patient’s biological status and to generate a risk score and four discrete risk categories. The risk categories correlate to a patient’s likelihood of deteriorating, represented by length of stay in the hospital, in-hospital mortality, and escalation of care within 24 hours. An intuitive user display reveals how patients’ parameters were used to calculate their final sepsis scores.
“Until now, there was no other FDA-authorized AI diagnostic for sepsis, which is why the Sepsis ImmunoScore had to be granted marketing authorization through the de novo pathway,” said Prenosis cofounder and CEO Bobby Reddy Jr., PhD, in a company press statement.
Prenosis, 312-235-3580
Federal government releases updated health IT plans
The federal Office of the National Coordinator for Health Information Technology has released two far-reaching documents to the public that address health information technology goals, progress, and issues.
The “2023 Report to Congress: Update on the Access, Exchange, and Use of Electronic Health Information through Trusted Networks,” also known as the HITECH report, describes actions the Department of Health and Human Services and public and private sector entities are taking to address issues related to health IT and support electronic health information access, exchange, and use. The report also updates progress on implementing the 2020–2025 Federal Health IT Strategic Plan. To access the report, go to https://bit.ly/3UhAM2m.
The draft 2024–2030 Federal Health IT Strategic Plan outlines the federal government’s health IT goals, objectives, and strategies for improving health equity, advancing scientific discovery, and modernizing the nation’s public health infrastructure. It also addresses the policies and technologies necessary to meet the diverse data requirements of health IT users. To access the draft plan, go to https://bit.ly/3xEhlrX. The public comment period for the draft plan ends May 28.
Gestalt introduces tool and enhances education module for digital pathology solution
Gestalt Diagnostics recently announced that it has released AI Algorithm Evaluator, a patent-pending tool to assess and compare the performance of artificial intelligence-based algorithms within the company’s PathFlow cloud-based digital pathology enterprise platform, and enhanced the education module within PathFlow.
The AI Algorithm Evaluator allows users to compare the results of similar algorithms side by side simultaneously. They can also customize scoring parameters to align with their requirements, monitor historical scores, identify trends, and make decisions based on long-term data. The tool too provides a digital audit trail that documents the basis on which algorithms are selected.
In a nutshell, a laboratory can use the product to identify the algorithm best suited to its specific clinical or research needs, said Roopam Kakoti, vice president of development at Gestalt, in a company press statement.
In a separate announcement, Gestalt reported that its education module within PathFlow now includes automated digital evaluation, proficiency testing, credentialing management, and results comparison features. PathFlow consists of professional, education, and research modules.
PathFlow is available for research use only in the United States, except when following CAP guidelines for laboratory-developed tests. It is CE-IVD certified for use in the European Union.
Gestalt Diagnostics, 509-492-4912
Availity adds claims-denial functionality to RCM platform
The health information network Availity has introduced Predictive Editing, claims-denial prediction functionality for its end-to-end revenue cycle management platform Availity Essentials Pro.
Artificial intelligence-enabled Predictive Editing analyzes historical claims, comparing them to remittance data to detect payment patterns. The patterns are used to flag new claims that are likely to be denied by a health plan so the claims can be corrected before they are submitted.
“Built and trained on a database of more than 3 billion medical and pharmacy claims, Predictive Editing’s AI engine is tuned to each provider’s payment environment and payers’ adjudication rules, creating and applying new edits in response to changing conditions,” according to a press release from Availity.
The AI engine was developed by Anomaly Insights and is being deployed as a partnership between Anomaly Insights and Availity.
Availity, 800-282-4548
Nucleai, GoPath Diagnostics partner on digital pathology
The spatial artificial intelligence biomarker company Nucleai has entered a strategic collaboration with the digital pathology and molecular diagnostics laboratory GoPath Diagnostics.
“Nucleai will integrate its suite of AI algorithms and digital pathology viewer with GoPath’s laboratory information management systems and laboratory management systems for real-time sharing of data, at scale, to enable centralized on-demand AI analysis to augment clinicians’ review of diagnostic pathology cases,” according to a press statement from both companies.
The vendors too will collaborate on research projects to explore predictive AI algorithms that could provide insights into prostate cancer and inflammatory bowel disease. They also intend to support sponsored clinical trials by providing centralized access to real-world training and validation data sets, molecular pathology services, and AI tools.
GoPath Diagnostics, 855-467-2849
BYG4lab appoints VP of sales for new U.S. subsidiary
The French company BYG4lab Group has named Tim Bickley, MLS(ASCP), vice president of sales for its U.S. market as the company opens a U.S. subsidiary in Chicago.
BYG4lab is a global software company specializing in clinical laboratory and diagnostic data-management solutions. It has more than 4,500 user laboratories worldwide.
Bickley has over 25 years of experience in the laboratory and diagnostics industry and has served as vice president of sales and marketing for other laboratory information solutions companies. He holds a master of business administration degree and a Certified Professional in Healthcare Information and Management Systems credential from the Healthcare Information and Management Systems Society.
“I am confident that our suite of software products and services, which we will begin rolling out in the coming weeks, will deliver unmatched benefits for patients and our customers,” Bickley said in an April press release.
BYG4lab, 205-710-7547
Dr. Aller practices clinical informatics in Southern California. He can be reached at rayaller@gmail.com. Dennis Winsten is founder of Dennis Winsten & Associates, Healthcare Systems Consultants. He can be reached at dennis.winsten@gmail.com.