Company Product Description Indication Status
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


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