Company Product Description Indication Status
Bittium Corp., of Oulu, Finland Brainstatus product family Compact, wireless electroencephalogram (EEG) system; consists of a wireless compact EEG amplifier, EEG measurement software and a disposable electrode headband For real-time, remote electrical activity monitoring of the brain in patients with altered levels of consciousness, such as epileptic seizures, or for detecting effects of brain hypoxia Received medical device approval in Europe
Camber Spine Technologies LLC, of King of Prussia, Pa. Spira-C integrated fixation system Stand-alone integrated fixation system For anterior cervical fusions Received 510(k) approval from the U.S. FDA
Grifols SA, of Barcelona, Spain Procleix Panther system featuring ART Single, integrated platform with significant hardware and software improvements that improve usability and increased operator walk-away time For nucleic acid technology-based blood screening in blood donation Received approval from the U.S. FDA
Neumodx Molecular Inc., of Ann Arbor, Mich. Neumodx SARS-CoV-2 Assay Rapid, automated in vitro real-time RT-PCR diagnostic test For the direct detection of SARS-CoV-2 RNA from nasopharyngeal, oropharyngeal, or nasal swab specimens; detects the Nsp2 gene and N gene Received the CE mark
Sherlock Biosciences Inc., of Cambridge, Mass. Sherlock CRISPR SARS-CoV-2 kit CRISPR-based diagnostic method; provides results in approximately 1 hour For the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage specimens Received emergency use authorization from the U.S. FDA

Notes

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

No Comments