|Avacta Group plc, of Wetherby, U.K.||Affidx SARS-CoV-2 antigen lateral flow test||Rapid antigen test||Detects SARS-CoV-2 viral antigens||Reported positive data from a clinical validation study in Europe across a broad range of viral loads; the study tested 98 positive samples with viral loads confirmed by PCR (31 with cycle threshold <26; 65 with cycle threshold 26-30 and 2 with cycle threshold 30-31); the test identified 96/98 of these correctly as positive with a 20 minutes read time, resulting in a clinical sensitivity of 98.0%; out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99.0%|
|Co-Diagnostics Inc., of Salt Lake City||Logix Smart COVID-19 test kit||In vitro diagnostic test that uses Coprimer technology||For the qualitative detection of RNA from SARS-CoV-2||Australian researchers demonstrated rapidly deployable mobile molecular diagnostics support for remote locations; when tested on clinical samples, the sensitivity and specificity of Co-Diagnostics's test showed complete concordance with the comparison assay; demonstrated an analytical sensitivity of 1,010 viral copies per milliliter, which they found to be comparable to other tests used across Western Australia; results were published in the Journal of Medical Microbiology|
|Limacorporate SpA, of Udine, Italy||Smr stemless reverse shoulder system||Prosthetic implant||For total reverse shoulder arthroplasty||First surgery was performed in the U.S. IDE study; the multicenter trial is evaluating the safety and effectiveness of the Smr stemless reverse shoulder system compared to the Smr reverse shoulder system; will enroll 200 patients with 2-year follow-up|
|Medtronic plc, of Dublin||In.Pact AV||Drug-coated balloon (DCB)||For treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis||The In.Pact AV Access study showed sustained and superior effectiveness through 2 years compared to standard percutaneous transluminal angioplasty (PTA) in ESRD patients with de novo or non-stented restenotic native arteriovenous fistulae in the upper extremity; target lesion primary patency through 24 months was 52.2% in the In.Pact AV DCB group vs. 36.2% in the PTA control group (log-rank p<0.001); access circuit primary patency through 24 months was 39.5% in the In.Pact AV DCB group vs. 25.4% in the PTA control group (log-rank p<0.001); freedom from all-cause mortality through 24 months was 82.4% in the In.Pact AV DCB study group vs. 82.8% in the PTA control group (log-rank p=0.829)|
|Phagenesis Ltd., of Manchester, U.K.||Phagenyx system||Neurostimulation device that using pharyngeal electrical stimulation (PES)||Treatment of intubation-induced severe neurogenic post-extubation dysphagia in COVID-19 patients||Published in Journal of Medical Case Reports the experience of a 71-year-old female patient with confirmed SARS-CoV-2 infection and severe neurogenic dysphagia following prolonged intubation in the ICU who was treated with PES using the Phagenyx system; patient demonstrated rapid improvement in saliva management with increased spontaneous swallowing and post-treatment diet advancement; patient was discharged from the ICU to a non-intensive medical department 5 days after final PES treatment session|
|Renalytix AI plc, of New York||Kidneyintelx||In vitro diagnostics platform for blood-based biomarkers that uses an artificial intelligence-enabled algorithm||Identifies early-stage patients at high risk for kidney disease progression and failure||Study found the Kidneyintelx test accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS) with early-stage DKD (stages I-III); participants identified by Kidneyintelx as high risk (15% of the study population) had more than an 8-fold higher rate of disease progression vs. those that scored low risk (42% of the population); the application of the guideline-recommended Kidney Disease: Improving Global Outcomes risk classification tool only provided a 2.5-fold gradient for DKD progression among study participants identified as high risk compared with those scored as low risk|
|Vivasure Medical Ltd., of Galway, Ireland||Perqseal+||Fully absorbable, patch-based implant||Sutureless closure of large-bore vessel punctures||Enrolled first patient in Frontier V study|
For more information about individual companies and/or products, see Cortellis.