|Gnomegen LLC, of San Diego||Gnomegen COVID-19 RT-Digital PCR Detection Ki||In vitro diagnostic; runs on Thermo Fisher Scientific's Applied Biosystems Quantstudio 3D Digital PCR system||For the qualitative detection of nucleic acid from the SARS-CoV-2 virus in nasal, nasopharyngeal and oropharyngeal swab specimens; only authorized for use by CLIA-certified laboratories||Received emergency use authorization from the U.S. FDA|
|Motus GI Holdings Inc., of Fort Lauderdale, Fla.||Gen2 Pure-Vu system||Device integrates with standard and slim colonoscopes to irrigate the colon and evacuate debris||Helps facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure||Received approval from the Israeli Ministry of Health, Medical Device Division to initiate commercial sales|
|Nitiloop Ltd., of Herzelia, Israel||Novacross CTO Microcatheter||Based on a nitinol scaffold; enables 0.014" guidewire support and centering||Facilitates the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions (CTO), prior to percutaneous transluminal coronary angioplasty or stent intervention||Received 510(k) clearance from the U.S. FDA|
|Orthosensor Inc., of Dania Beach, Fla.||Verasense||Single-use intelligent sensor for use with the the Zimmer Biomet Persona Knee implant system||Measures tibial coronal alignment and quantifies soft-tissue balance||Received 510(k) clearance from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.