Company Product Description Indication Status
Adaptive Biotechnologies Corp., of Seattle T-Detect COVID Next-generation sequencing based test that analyzes DNA sequences from T cells Aids in identifying individuals with an adaptive T cell immune response to SARS-CoV-2 Received emergency use authorization from the U.S. FDA
Cochlear Ltd., of Sydney Baha 6 Max Bone conduction sound processor For people with single-sided deafness, conductive or mixed hearing loss Received 510(k) clearance from the U.S. FDA
Ortho Clinical Diagnostics Inc., of Raritan, N.J. Vitros Anti-SARS-CoV-2 Total 2 Antibody assay Immunoassay For the qualitative and semi-quantitative detection of SARS-CoV-2 antibodies Received the CE mark
Ortho Clinical Diagnostics Inc., of Raritan, N.J. Vitros Anti-SARS-CoV-2 IgG 2 Antibody assay Immunoassay For the qualitative and semi-quantitative detection of SARS-CoV-2 antibodies Received the CE mark
Promaxo Inc., of Oakland, Calif. Promaxo MRI system Single-side MRI system that can be used in an office or outpatient surgical setting Provides guidance for urologists and interventional/urologic radiologists to perform surgical localization of prostatic lesions Received 510(k) clearance from the U.S. FDA
Siemens Healthineers AG, of Erlangen, Germany Biograph Vision Quadra Extended axial field of view PET/CT scanner Enables simultaneous whole-body imaging (vertex to thighs) Received 510(k) clearance from the U.S. FDA

Notes

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