Company Product Description Indication Status
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

Notes

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

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