Company Product Description Indication Status
4web Medical, of Frisco, Texas Stand-Alone Anterior Lumbar Interbody Fusion Device 3D printed Truss Implant technology; allows fixation screws to be placed through the truss implant and into the adjacent vertebral bodies For use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at
one or two contiguous disc levels
Received 510(k) clearance from the U.S. FDA
Atomic Blue LLC, of Houston UV-C germicidal light High-performance LED ultraviolet (UV) C light For disinfection of viruses and bacteria, including SARS-CoV-2 Received U.S. FDA approval as a class 1 device
Dexcom Inc., of San Diego Dexcom G6 Continuous glucose monitoring system that uses uses a small, wearable sensor and transmitter to send glucose levels wirelessly to a dedicated receiver or compatible smart device Gives patients with diabetes real-time glucose data without the need to prick their finger and helps avoid low and high blood sugar events Received the CE mark for use on the upper arm; previously received the CE mark for use on the abdomen
Hangzhou Biotest Biotech Co. Ltd., of Hangzhou, China Rightsign COVID-19 IgG/IgM Rapid Test Cassette Serological test For the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human serum, plasma, and venous whole blood (sodium heparin, potassium EDTA, and sodium citrate) Received emergency use authorization from the U.S. FDA
Incelldx Inc., of San Carlos, Calif. Oncotect 3Dx Identifies and quantifies 3 molecular markers of cervical cancer: overexpression of oncogenes (E6, E7 mRNA), proliferation and aneuploidy For the detection of cervical cancer Received approval from the Costa Rican Ministry of Health
Seasun Biomaterials Inc., of Daejeon, South Korea AQ-TOP COVID-19 Rapid Detection Kit 20-minute molecular test kit; used with an RT-PCR instrument For the qualitative detection of nucleic acid from SARS-CoV-2 upper and lower respiratory specimens including oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens, bronchoalveolar lavage (BAL) and sputum Received emergency use authorization from the U.S. FDA
Sekisui Diagnostics LLC, of Burlington, Mass. Osom Ultra Plus Flu A&B Test Lateral flow test For the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection Received 510(k) clearance from the U.S. FDA
Vasoptic Medical Inc., of Baltimore Xycam RI Noninvasive retinal imager; captures and provides dynamic blood flow information Aids in assessing the vascular status of the retina 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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