Company Product Description Indication Status
Lumos Diagnostics, of Sarasota, Fla. Febridx Point-of-care fingerstick blood test; uses two biomarkers, Myxovirus resistance protein A and C-reactive protein Assesses and differentiates viral from bacterial symptomatic respiratory infections Published a COVID-19 (SARS-CoV-2) clinical trial in The International Journal of Clinical Practice; Kettering General Hospital analyzed 47 eligible patients of which 34 had a diagnosis of COVID-19; Febridx detected 34/34 COVID-19 infections vs. a SARS-CoV-2 molecular test that detected 29/34 (85.3%) on initial test; the specificity of both tests was 100%; the delay in diagnosis with PCR meant that patients who did not have COVID-19 were inadvertently exposed to COVID-19 positive patients whilst awaiting confirmatory testing; the Febridx test also correctly identified 8/8 bacterial infections with a sensitivity of 100% and a specificity of 92% for bacterial infection
Theranica Bio-Electronics Ltd., of Netanya, Israel Nerivio Smartphone-controlled prescription wearable device For acute migraine treatment Published a real-world postmarketing surveillance study in Pain Medicine that demonstrates the safety, efficacy and consistency of Nerivio; the study evaluated 2 cohorts of patients with episodic and chronic migraine treated with Nerivio; one group utilized in-person visits with headache specialists, while the other cohort included patients who were managed through a single-specialty or multispecialty online telemedicine platform; the headache specialist group consisted of 1,339 evaluated patients and 2,875 treatments; 58.9% of these patients experienced pain relief, 20% experienced pain freedom at 2 hours in at least half of their treated attacks, and 52.9% and 25.8% reported an improvement or a complete return to normal functioning, respectively, 2 hours after starting the treatment; the telemedicine cohort consisted of 45 evaluated patients and 78 treatments; 74.2% of the patients in this group experienced pain relief, 35.6% experienced pain freedom at 2 hours in at least half of their treated attacks, and 66.7% and 51.3% reported an improvement or a return to normal functioning, respectively; only 0.5% of all patients experienced any kind of adverse event, and all adverse events were categorized as mild, non-systemic, and resolved within less than 24 hours

Notes

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