|Clearmask LLC, of Baltimore||Clearmask||Fully transparent surgical mask||Provides protection for medical use||Received 510(k) clearance from the U.S. FDA|
|Diazyme Laboratories Inc., of Poway, Calif.||Diazyme DZ-Lite SARS-CoV-2 IgM test||Antibody test; runs on the fully automated DZ-Lite 3000 Plus chemiluminescence analyzer||For the qualitative detection of IgM antibodies to SARS-CoV-2||Received emergency use authorization from the U.S. FDA|
|Genosity Inc., of Iselin, N.J.||Astra||Tumor exome and liquid biopsy cancer monitoring platform||Identifies a patient's unique tumor molecular profile that can be used for ongoing, personalized minimal residual disease monitoring||Received CLIA approval|
|Illuminoss Medical Inc., of East Providence, R.I.||Photodynamic Bone Stabilization system||Uses a light-curable liquid monomer, contained within an expandable balloon, to create a patient-conforming, rigid implant within the bone canal||For minimally invasive orthopedic fracture repair and stabilization||Received expanded 510(k) clearance from the U.S. FDA for use in fibula fractures; was previously cleared for the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, metacarpals, metatarsals, and phalanges|
|Sensiva Health LLC, of New Orleans||Sensiva C19 COVID-19 test||RT-PCR molecular test||For the qualitative detection of nucleic acid from SARS-CoV-2||Received emergency use authorization from the Caribbean Public Health Agency|
For more information about individual companies and/or products, see Cortellis.