|Acarix AB, of Malmö, Sweden||CADScor system||Uses an advanced sensor placed on the skin above the heart to listen to the sounds of cardiac contraction movement and turbulent flow||Improves the diagnosis of patients with potential coronary artery disease (CAD)||The U.S. FDA approved its de novo application for marketing approval|
|Applied DNA Sciences Inc., of Stony Brook, N.Y.||Linea COVID-19 assay kit||RT-PCR test||For the qualitative detection of nucleic acid from SARS-CoV-2||The U.S. FDA granted an emergency use authorization amendment; expands the RT-PCR platform authorization from the Quantstudio Dx and Quantstudio 5 Real-Time PCR systems to also include the 7500 Fast Dx Real-Time PCR system|
|Co-Diagnostics Inc., of Salt Lake City, and Cosara Diagnostics Pvt. Ltd., of Gujarat, India||Saragene COVID-19 2-gene multiplex RT-PCR test||RT-PCR test||For the qualitative detection of the SARS-CoV-2 virus (targets RdRp and E-gene)||Received clearance by the Central Drugs Standard Control Organization in India to manufacture and sell the COVID-19 test|
|Corticometrics LLC, of Boston||Thinq||Artificial intelligence-based software||For automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of magnetic resonance images; volumetric measurements may be compared to reference percentile data||Received 510(k) clearance from the U.S. FDA|
|Kantaro Biosciences LLC, of New York||COVID-Seroklir||Semi-quantitative SARS-CoV-2 IgG antibody test kit; 2-step enzyme-linked immunosorbent assay (ELISA)||For determining the presence and precise level of SARS-CoV-2 specific IgG antibodies||Received emergency use authorization from the U.S. FDA|
|Rapidrona Inc., of Chicago||Rapidrona Self-Collection Kit||Home collection kit||For use by individuals for self-collection of nasal swab specimens at home, when determined by a health care provider to be appropriate based on the results of an online COVID-19 questionnaire||Received emergency use authorization from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.