|Acarix AB, of Malmö, Sweden||Modified CADscor system||Algorithm-based platform that obtains additional seismocardiographic data||Differentiates patients referred with suspicion of heart failure||Reported positive preliminary data from its exploratory heart failure study SEISMO; showed a low prevalence of heart failure in patients referred for heart failure evaluation at an outpatient clinic, making a reliable and fast rule-out method highly relevant|
|Exact Sciences Corp., of Madison, Wis.||Cologuard||Stool DNA test||Colorectal cancer screening||Study results show that among average-risk adults ages 45-49, Cologuard demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions or negative findings at colonoscopy and 96.3% in only those with negative colonoscopy findings; analyses support potential risk mitigation and cost prevention due to unnecessary diagnostic procedures when using Cologuard as a colorectal cancer screening tool in this younger population; published data in Cancer Prevention Research|
|Glaukos Corp., of San Clemente, Calif.||Idose TR||Sustained-release travoprost implant||Decreases intraocular pressure (IOP) in patients with glaucoma||Reported interim results from the 154-subject phase IIb IND trial, which was designed to evaluate a single administration of 1 of 2 Idose TR models with different travoprost release rates vs. topical timolol ophthalmic solution; average IOP reductions from baseline observed during the first 24 months were 7.9 mmHg (29%) and 7.4 mmHg (28%) in the fast- and slow-release Idose TR arms, respectively, vs. 7.8 mmHg (30%) in the timolol control arm; over the first 24 months, 23% and 20% of subjects in the fast- and slow-release Idose TR arms reported average IOP reductions from baseline of at least 40%, respectively, vs. 13% in the timolol control arm|
|Glaukos Corp., of San Clemente, Calif.||Istent Infinite||Trabecular micro-bypass system||Decreases intraocular pressure (IOP) in patients with glaucoma||12-month U.S. IDE pivotal trial data showed that its Istent Infinite achieved a substantial reduction in mean diurnal IOP in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy; 72 patients entered the pivotal study with a mean baseline IOP of 23.4 mmHg on an average of 3.1 medications and an average of 2 failed prior surgeries; at 12 months, 76% of subjects achieved 20% or greater reduction in mean diurnal IOP from baseline on the same or lower ocular hypotensive medication burden; more than 50% of subjects achieved Month 12 IOP reduction ≥ 30%; subjects also achieved a 13% mean reduction in medication burden at 12 months|
|Nexstim plc, of Helsinki||Smartfocus nTMS||Navigated transcranial magnetic stimulation (nTMS) technology with 3D navigation||For presurgical mapping of the speech and motor cortices of the brain||Study including 140 consecutive patients with suspected language-eloquent brain tumors was published in Cancers; Smartfocus nTMS was performed on all these patients; in a very high number of patients, the tumor could be removed to the maximum extent, with gross total resection achieved in 82.3% of cases|
|Lumiradx UK Ltd., of London||Lumiradx SARS-CoV-2 Antigen Test||Uses fast microfluidic immunofluorescence technology||For the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab specimens||The Scandinavian evaluation of laboratory equipment for point-of-care testing published a positive evaluation of the Lumiradx test, which was conducted in 448 subjects, including 197 who were asymptomatic; positive agreement of Lumiradx test vs. to RT-PCR was 87% in nasal samples and 90% in nasopharyngeal samples; overall negative agreement of Lumiradx test vs. RT-PCR was 99.5% in nasal samples and 97.8% in nasopharyngeal samples; in patients with viral load corresponding to Ct below 33, the positive agreement was 92% in nasal samples and 95% in nasopharyngeal samples, irrespective of symptoms|
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