Company Product Description Indication Status
Biosig Technologies Inc., of Westport, Conn. Pure EP system Computerized system for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals For patients undergoing electrophysiology (EP) procedures Identical electrocardiographic and intracardiac signal data were recorded during 15 atrial fibrillation ablation procedures from the Pure EP system, the signal recording system, and the 3D mapping system; the collected signals underwent blinded, controlled evaluation by 3 independent electrophysiologists to determine whether the Pure EP signals are a viable alternative to conventional sources and if it provides additional or clearer diagnostic information; reviewers were asked to record the quality of each signal sample on a scale of 1-10 and select a rationale for their rating in a dropdown menu; based on the ratings for each pair of signals, a cumulative total of Pure EP signals out of 34 (85.3%) were rated as statistically equivalent or better for this dataset; in 35.5% of samples, the reviewers selected Pure EP data because "more signal components were visible"; concluded that the Pure EP system is able to produce reliable and high-quality signals when compared to the available standard of care systems
Icad Inc., of Nashua, N.H. Profound AI Risk Artificial intelligence (AI) software that combines aspects within mammographic images as well as age and breast density Provides clinicians with a 2-year breast cancer risk category (low, general, moderate and high) and absolute breast cancer risk score for each patient Data supporting Profound AI Risk was published in Radiology; the study led by researchers at the Karolinska Institutet was based on the prospective screening cohort, KARolinska MAmmography Project for Risk Prediction of Breast Cancer (KARMA), which recruited women from 2011-2017; of 70,877 participants in the KARMA cohort, 974 women with incident cancers and 9,376 healthy women were sampled; Profound AI Risk reached an area under the curve (AUC) of 0.73 (95% CI: 0.71, 0.74), indicating high accuracy for risk assessment; researchers found a statistically significant superior performance when comparing the Profound AI Risk model to existing risk models at 2 years, such as the Tyrer-Cusick v8 model (+11 points) or GAIL model (+12 points), all including breast density within their calculations
Immunexpress Inc., of Seattle Septicyte Rapid Assay that provides results in about 1 hour Detects sepsis Study compared Immunexpress' rapid version of the Septicyte assay on the Biocartis Idylla platform to Septicyte Lab in patients located in the U.S. and Europe; data demonstrates comparable and reproducible results between Septicyte Lab and Septicyte Rapid to differentiate sepsis from noninfectious systemic inflammation
Immunexpress Inc., of Seattle Septicyte Assess a patient's dysregulated immune response by quantifying and analyzing gene expression from whole blood Differentiates patients with sepsis from those with noninfectious systemic inflammation Study demonstrated diagnostic performance of the Septicyte technology across a broad range of patients, including adults, children and neonates, and in hospital locations outside the ICU; diagnostic performance was determined using Area Under Curve (AUC); Septicyte AUCs for the 3 groups of adults, pediatric/neonates and adult/pediatric were 0.88, 0.87, and 0.85, respectively, which is similar to that previously reported for adults only (0.82-0.89)

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