Company Product Description Indication Status
Agnovos Healthcare, of New York AGN1 Local Osteo-enhancement Procedure small volume kit Contains a proprietary, calcium-based, resorbable, tri-phasic implant material and instruments for preparation and inection For the treatment of painful but stable vertebral compression fractures that are often caused by bone loss associated with osteoporosis Received breakthrough device designation from the U.S. FDA
Conversion Labs Inc., of New York Shapiro MD Laser 272 Battery-powered, low-level laser therapy helmet Promotes hair growth in women and men by exposing the scalp to photobiostimulation generated by 272 light emitting diodes Received 510(k) clearance from the U.S. FDA
Immunexpress Inc., of Seattle Septicyte Rapid Gene expression assay using reverse transcription polymerase chain reaction; for use on the Biocartis Idylla system For the early diagnosis of bacterial and viral sepsis; generates a Septiscore based on the increasing likelihood of infection-positive systemic inflammation Received CE-IVD marking
Prisma Health, of Greenville, S.C. Vesper Ventilator expansion device produced using 3D printing technology Acts as a Y connector to allow a single ventilator to support up to 4 patients during times of acute equipment shortages Received emergency use authorization from the U.S. FDA
Quidel Corp., of San Diego Lyra SARS-CoV-2 Assay Real-time RT-PCR test For the detection of nucleic acid from SARS-CoV-2 from patients suspected of COVID-19; testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 Received expanded emergency use authorization from the U.S. FDA to allow testing with 3 additional thermocyclers: Applied Biosystems 7500 Standard, Roche Lightcycler 480, and Qiagen Rotor-Gene Q; acceptable specimens have been expanded by the CDC to include nasal and nasal turbinate swabs
Quidel Corp., of San Diego Lyra SARS-CoV-2 Assay Real-time RT-PCR test For the detection of nucleic acid from SARS-CoV-2 from patients suspected of COVID-19 Received the CE mark
Quidel Corp., of San Diego Lyra SARS-CoV-2 Assay Real-time RT-PCR test For the detection of nucleic acid from SARS-CoV-2 from patients suspected of COVID-19 Received authorization from Health Canada
Vero Biotech LLC, of Atlanta Genosyl DS Inhaled nitric oxide delivery system (DS) Improves oxygenation and reduces the need for extracorporeal membrane oxygenation; previously approved for the treatment of persistent pulmonary hypertension of the newborn The U.S. FDA granted expanded access emergency use authorization to be used for the treatment of cardiopulmonary symptoms associated with COVID-19

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

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