|Beckman Coulter Diagnostics, of Brea, Calif.||Access SARS-CoV-2 IgG assay||Serology test; 100% sensitivity and 99.6% specificity||For the qualitative detection of IgG antibodies to SARS-CoV-2||Received emergency use authorization from the U.S. FDA|
|Boston Scientific Corp., of Marlborough, Mass.||Lux-Dx||Insertable cardiac monitor system; uses a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians||Detects arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke and syncope||Received 510(k) clearance from the U.S. FDA|
|Envoy Medical Corp., of White Bear Lake, Minn.||Acclaim||Cochlear implant without any external components||Improves the hearing of adults diagnosed with moderate to profound sensorineural hearing loss||Received breakthrough device designation from the U.S. FDA|
|Orthofix Medical Inc., of Lewisville, Texas||Firebird||Sacroiliac (SI) joint fusion system; a 3D-printed titanium bone screw||Treats low back pain caused by SI joint dysfunction||Received 510(k) clearance from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.