Company Product Description Indication Status
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

Notes

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

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