Company Product Description Indication Status
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

Notes

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

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