Austin, Texas-based Closedloop.ai, health care’s data science platform, has won the CMS Artificial Intelligence Health Outcomes Challenge. Closedloop beat out more than 300 other companies to win the $1.6 million prize.
Reno, Nev.-based Echelon Diagnostics Inc., a provider of genomic health care artificial intelligence imaging analysis and big data solutions, and San Diego-based Cradle Genomics Inc., inventors of a prenatal testing methodology, reported an agreement that will help accelerate the development of Cradle’s cellular-based non-invasive prenatal diagnosic products. As part of the agreement, Echelon is providing expertise using its Prenataldx technology to help enhance the data analysis and reporting capabilities for Cradle’s comprehensive fetal genetic analysis and health screening solutions.
Bedford, Mass.-based Ocular Therapeutix Inc., has received notification from the FDA confirming it has fulfilled all post-approval study requirements for Resure sealant, with a requirement to update the Resure label reflecting the study results. As a condition for Resure’s pre-market approval (PMA) application in 2014, the FDA required two post-approval studies to be completed. The first, referred to as the clinical post-approval study, was completed in 2016. This notification marks the completion of the second, the device exposure registry study, a retrospective analysis comparing endophthalmitis rates from sites that purchased Resure sealant vs. sites that did not. Overall, the results of the study demonstrated there was no clinically or statistically significant difference in the incidence of endophthalmitis within 30 days of any cataract surgery between cohorts with and without access to Resure sealant. Ocular plans to submit a PMA supplement to modify the existing Resure label to reflect the findings from the recently completed study.
New Haven, Conn.-based specialty diagnostics company Precipio Inc. successfully launched its COVID-19 rapid antibody test (20 minute) which tests for both IgG & IgM antibodies, on Amazon.com's business platform. Precipio holds the exclusive rights to distribute this product on Amazon’s platform. The antibody test, which is manufactured in the U.S. by Nirmidas Biotech, of California, was the first U.S.-based test to receive emergency use authorization by the FDA for point-of-care.
Stockholm, Sweden-based Raysearch Laboratories AB reported a sales agent agreement has been signed with Tustin, Calif-based Canon Medical Systems USA Inc., enabling Raysearch America's salesforce to promote Canon Medical's Aquilion large bore CT and Celesteion PET/CT products. Together, the companies will bring their integrated radiation oncology portfolio to more U.S. customers to further enhance care for cancer patients.