Company Product Description Indication Status
Aegea Medical Inc., of Menlo Park, Calif. Mara Water vapor ablation system Endometrial ablation treatment to reduce heavy menstrual bleeding; for use in the doctor's office without the need for general anesthesia Received U.S. FDA PMA approval
Biolase Inc., of Irvine, Calif. Epic Hygiene Laser Dental laser system For the early management of periodontal disease Received regulatory clearance for laser bacterial reduction therapy indication from the U.S. FDA
Biomérieux SA, of Marcy l'Etoile, France, subsidiary Biofire Defense Biofire COVID-19 test Test runs on the fully automated Filmarray 2.0 and Filmarray Torch platforms For use in CLIA moderate and high complexity clinical laboratories to detect SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media Received emergency use authorization by the U.S. FDA
Diacarta Inc., of Richmond, Calif. Quantivirus SARS-CoV-2 test In vitro diagnostic test based on real-time PCR technology; targets the N, Orf1ab and E genes For specific detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected with coronavirus infection Received emergency use authorization by the U.S. FDA
Diacarta Inc., of Richmond, Calif. Quantivirus SARS-CoV-2 test In vitro diagnostic test based on real-time PCR technology; targets the N, Orf1ab and E genes For specific detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected with coronavirus infection Received CE mark
Helius Medical Technologies Inc., of Newtown, Pa. Portable Neuromodulation Stimulator (PoNS) device Nonimplantable medical device For the short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy and indicated as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS) and is to be used in conjunction with physical therapy Its Canadian class II license amendment application for the treatment of gait deficit in patients with mild and moderate symptoms from MS has received marketing authorization from Health Canada
Mesa Biotech Inc., of San Diego Accula SARS-CoV-2 test Visually read test using polymerase chain reaction technology for results in approximately 30 minutes Detects SARS-CoV-2 via throat and nasal swab samples Received emergency use authorization by the U.S. FDA

Notes

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

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