Company Product Description Indication Status
Diazyme Laboratories Inc., of Poway, Calif. Dz-Lite SARS-CoV-2 IgG test Antibody test; runs on the fully automated Dz-Lite 3000 Plus chemiluminescence analyzer Detects SARS-CoV-2 IgG antibodies based on S and N proteins Received updated emergency use authorization from the U.S. FDA to allow use as a semi-quantitative test; was previously authorized as a qualitative test
Helio Health, of Irvine, Calif. Helio Liver test Cell-free DNA methylation blood test Detects hepatocellular carcinoma The China National Medical Products Administration has accepted the its registration application
Letsgetchecked Inc., of New York Letsgetchecked Coronavirus (COVID-19) test At-home polymerase chain reaction nasal swab test For SARS-CoV-2 testing of anterior nasal swab specimens self-collected at home Received updated emergency use authorization from the U.S. FDA to allow use without a prescription
Mesi Ltd., of Ljubljana, Slovenia Mesi Mtablet ABI Tablet device with wireless diagnostic modules that connect to electronic medical records For early detection of peripheral arterial disease by measuring Ankle-Brachial Index (ABI) Received 510(k) clearance from the U.S. FDA
Natera Inc., of San Carlos, Calif. Signatera Personalized, tumor-informed circulating tumor DNA assay Companion diagnostic for different cancer therapies U.S. FDA granted 2 breakthrough device designations
Tempus Labs Inc., of Chicago ECG Analysis Platform Device analyzes the results of a 12-lead ECG using artificial intelligence Aids clinicians in identifying patients at increased risk of developing atrial fibrillation or atrial flutter U.S. FDA granted breakthrough device designation
Tivic Health Systems Inc., of Menlo Park, Calif. Clearup Hand-held device that delivers microcurrent waveforms on the outside of nasal passages Helps relieve sinus pain and congestion U.S. FDA expanded the indication for use to include congestion from allergies, the flu and the common cold; previously cleared for treating allergy-related sinus pain caused by seasonal and year-round allergies
Twist Bioscience Corp., of South San Francisco, and Biotia Inc., of New York SARS-CoV-2 NGS assay In vitro diagnostic test; combines Twist Bioscience's SARS-CoV-2 synthetic RNA controls and Biotia COVID-DX software For the qualitative detection of SARS-CoV-2 RNA Received emergency use authorization from the U.S. FDA

Notes

For more information about individual companies and/or products, see Cortellis.