Company Product Description Indication Status
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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