Company Product Description Indication Status
Mauna Kea Technologies, of Paris Cellvizio Probe- and needle-based confocal laser endomicroscopy platform Allows for imaging of the internal microstructure of tissues Published meta-analysis in the European Journal of Gastroenterology & Hepatology on endoscopic ultrasound guided needle-based confocal laser endomicroscopy for pancreatic cystic lesion evaluation; 10 studies enrolling 536 patients were included and the authors evaluated diagnostic accuracy, pooled sensitivity, specificity and mean procedural time; concluded that confocal laser endomicroscopy "clearly outperformed" endoscopic ultrasound fine-needle aspiration in terms of diagnostic accuracy (odds ratio 3.94, 1.58–9.82; P = 0.003) and supports the use of needle-based confocal laser endomicroscopy as a safe and effective tool in the diagnostic algorithm of pancreatic cysts
Mauna Kea Technologies, of Paris Cellvizio Probe- and needle-based confocal laser endomicroscopy platform Allows for imaging of the internal microstructure of tissues Published report in Endoscopy International Open on endoscopic ultrasound guided needle-based confocal laser endomicroscopy (EUS-nCLE) for pancreatic cystic lesion (PCL) evaluation; findings were based on consensus statements from an international panel of 15 experts in pancreatic disease that conducted evidence-based reviews of the applications, outcomes, procedural processes, indications, training, and credentialing of EUS-nCLE in the management of PCLs; reflected a high level of agreement pertaining to expert consensus statements; established that EUS-nCLE is a minimally invasive procedure that improves evaluation of PCLs and "should be systematically considered" when endoscopic ultrasound fine-needle aspiration is indicated for PCL evaluation
Truvian Sciences Inc., of San Diego Easy Check COVID-19 IgM/IgG antibody test Lateral flow test Detects IgM/IgG antibodies to SARS-CoV-2 In validation study, Easy Check had a sensitivity of 96.6%, specificity of 98.2% and an overall accuracy of 98.1%; Easy Check performance was tested against Roche's Elecsys Anti-SARS-CoV-2 antibody assay and showed an overall concordance of 98.6%, demonstrating it compares well with large lab-based serology analyzers

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