Abstract: A system and method for atrial fibrillation detection in non-noise ECG data with the aid of a digital computer are provided. Electrocardiography (ECG) features and annotated patterns of the features are maintained in a database, at least some of the patterns associated with atrial fibrillation. A classifier is trained based on the annotated patterns, the classifier implemented by a convolutional neural network. A representation of an ECG signal recorded by one or more ambulatory monitors is received. Noise is detected in the representations and ECG features in the representation falling within each of the non-noise temporal windows are detected. The trained classifier is used to identify patterns of the ECG features. A value indicative of whether portions of the representation are associated the patient experiencing atrial fibrillation is calculated. That one or more of the portions are associated with the patient experiencing atrial fibrillation is determined.
Type:
Grant
Filed:
September 16, 2022
Date of Patent:
June 20, 2023
Assignee:
Bardy Diagnostics, Inc.
Inventors:
Rodney Boleyn, Ezra M. Dreisbach, Chuck Dulken, Gust H. Bardy
Abstract: A subcutaneous and cutaneous electrocardiography monitor configured for self-optimizing ECG data compression is provided. The monitors include a housing, an electrocardiographic front end circuit, a memory, and a micro-controller configured to: obtain a series of electrode voltage values based on the sensed electrocardiographic signals; use a plurality of selection schemes to choose one or more of a plurality of compression algorithms associated with each of the selection scheme for testing; test the selected compression algorithms including applying the compression algorithms chosen using each of the selection schemes to a segment of the electrode voltage series; analyze results of the testing; select one or more compression algorithms chosen using one of the selection schemes for compressing at least a portion of the electrode voltage series based on the analysis; obtain a compression of at least the portion of the electrode voltage series; and store the compression within the memory.
Type:
Grant
Filed:
September 14, 2022
Date of Patent:
June 20, 2023
Assignee:
Bardy Diagnostics, Inc.
Inventors:
Gust H. Bardy, Jason Felix, Ezra M. Dreisbach
Abstract: A system for recording, storing and processing diagnostic information, including: a computer implementing a computer-readable media including digital data and ground truth; a registry constructed and arranged to store and associate transactions or accesses on the data; and a machine learning system that considers each learning step modification a microtransaction for the data used in that step and which is recorded in the transaction registry. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.
Abstract: Systems, devices, apparatus, methods, and computer-readable storage media for developmental assessment using eye tracking are provided. In one aspect, a system for development assessment via eye tracking includes: a patient-side computing device having a screen for presenting visual stimuli to a patient, an eye-tracking device integrated with the patient-side computing device and configured to collect eye-tracking data of the patient while the visual stimuli are presented to the patient on the screen of the patient-side computing device, and an operator-side computing device configured to present a user interface for an operator to communicate with the patient-side computing device.
Type:
Grant
Filed:
September 2, 2022
Date of Patent:
June 6, 2023
Assignee:
EarliTec Diagnostics, Inc.
Inventors:
Sreeni Narayanan, Ella Swanson-Hysell, Eli Johnson, Steven Shifke, Jason Davis, Connor Eck, Robin Sifre
Abstract: An illumination unit is described that includes a first light source positioned on a first axis and a second light source on a second axis that intersects and is angularly offset with respect to the first axis. The illumination unit includes a reflector having an aperture through which the first axis extends and a reflective surface angled with respect to the first axis and second axis.
Abstract: Analyzers and methods for making and using analyzers are described such as a method in which multiple absorption readings of a liquid assay are obtained by a photodetector using multiple light sources having at least three separate and independent wavelength ranges and with each of the absorption readings taken at a separate instant of time. Using at least one processor and calibration information of the liquid assay, an amount of at least two analytes within the liquid assay using the multiple absorption readings is determined.
Abstract: Long-term electrocardiographic and physiological monitoring over a period lasting up to several years in duration can be provided through a continuously-recording insertable cardiac monitor. The sensing circuitry and the physical layout of the electrodes are specifically optimized to capture electrical signals from the propagation of low amplitude, relatively low frequency content cardiac action potentials, particularly the P-waves that are generated during atrial activation and storing samples of captured signals. In general, the ICM is intended to be implanted centrally and positioned axially and either over the sternum or slightly to either the left or right of the sternal midline in the parasternal region of the chest.
Abstract: The invention provides methods for determining the MSI status of a patient by liquid biopsy with sample preparation using hybrid capture and non-unique barcodes. In certain aspects, the invention provides a method of detecting microsatellite instability (MSI). The method includes obtaining cell-free DNA (cfDNA) from a sample of blood or plasma from a patient and sequencing portions of the cfDNA to obtain sequences of a plurality of tracts of nucleotide repeats in the cfDNA. A report is provided describing an MSI status in the patient when a distribution of lengths of the plurality of tracts has peaks that deviate significantly from peaks in a reference distribution.
Abstract: Methods and reagents are disclosed for minimizing a false result in an assay measurement for determining a concentration of an analyte in a sample suspected of containing the analyte. The method comprises pretreating both an antibody and a sample to be subjected to a non-agglutination immunoassay. In the method the antibody and the sample are combined with a pretreatment agent selected from the group consisting of hydroxyphenyl-substituted C1-C5 carboxylic acids and metallic salts thereof and halogen-substituted C1-C5 carboxylic acids and metallic salts thereof in an amount effective to enhance the accuracy of the non-agglutination immunoassay.
Abstract: A biological sample preparation and reverse crosslink treatment reagent is disclosed in which all molecular pre-analytical and sample preparation steps can be performed on the biological sample in the single reagent. Also disclosed are kits containing the treatment reagent and methods of producing and using the treatment reagent.
Abstract: Many regions of genomic DNA are highly similar to other regions of the genome and thus are very difficult to capture without also capturing the similar, undesired regions. This leads to over-sequencing of regions for which there is no interest and lowers coverage of the desired regions. To minimize the capture of non-desired regions, blocking baits have been designed to prevent similar but non-desired fragments from being captured. This allows more directed sequencing of the regions of interest. Blocking baits differ from capture baits in that they have modestly different sequence that preferentially bind the non-desired DNA and do not contain a biotin or other modification so remain behind when the capture baits are selected.
Abstract: A neural network-based method for quantifying a volume of a specimen. The method includes providing a specimen, capturing images of the specimen, and directly classifying to one of a plurality of volume classes or volumes using a trained neural network. Quality check modules and specimen testing apparatus adapted to carry out the volume quantification method are described, as are other aspects.
Type:
Grant
Filed:
July 25, 2018
Date of Patent:
May 23, 2023
Assignee:
Siemens Healthcare Diagnostics Inc.
Inventors:
Stefan Kluckner, Yao-Jen Chang, Kai Ma, Vivek Singh, Terrence Chen, Benjamin S. Pollack
Abstract: The present invention relates to methods of detecting novel mutations in a PKD1 and/or PKD2 gene that have been determined to be associated with autosomal dominant polycystic kidney disease (ADPKD) in order to detect or predict the occurrence of ADPKD in an individual.
Type:
Grant
Filed:
August 31, 2020
Date of Patent:
May 23, 2023
Assignees:
Athena Diagnostics, Inc., The Johns Hopkins University
Inventors:
Terry J. Watnick, Miguel Garcia-Gonzalez, Gregory G. Germino, Jeffery G. Jones
Abstract: Reagents, kits, and microfluidics devices are disclosed for detecting the presence and/or concentration of antibodies directed to microorganisms in human biological samples. Also disclosed are methods of production and use of the reagents, kits, and microfluidics devices. Anti-human immunoglobulin antibodies are utilized to enhance the signal produced by the assay.
Abstract: Disclosed herein are immunoassay methods and reagents for detecting anti-Zika IgM antibody in a biological sample from a subject and/or diagnosing Zika virus infection in a subject. Also disclosed are algorithms for implementing the disclosed methods. The disclosed immunoassay methods, reagents, and algorithms enable efficient and reliable qualitative detection of anti-Zika virus antibodies and rapid determination of presumptive positive results for Zika virus infection in human subjects.
Abstract: Calibration and/or quality control reagents are disclosed for use in serology immunoassays for antibodies to a microorganism. In the reagents, antibodies specific to an antigen of the microorganism are complexed with anti-human Ig antibody to form a complex. Kits and microfluidics devices containing the reagents are also disclosed, along with methods of producing and using the reagents.
Abstract: A model-based method for quantifying a specimen. The method includes providing a specimen, capturing images of the specimen while illuminated by multiple spectra at different nominal wavelengths, and exposures, and classifying the specimen into various class types comprising one or more of serum or plasma portion, settled blood portion, gel separator (if used), air, tube, label, or cap; and quantifying of the specimen. Quantifying includes determining one or more of: a location of a liquid-air interface, a location of a serum-blood interface, a location of a serum-gel interface, a location of a blood-gel interface, a volume and/or a depth of the serum or plasma portion, or a volume and/or a depth of the settled blood portion. Quality check modules and specimen testing apparatus adapted to carry out the method are described, as are other aspects.
Type:
Grant
Filed:
January 24, 2017
Date of Patent:
May 16, 2023
Assignee:
Siemens Healthcare Diagnostics Inc.
Inventors:
Stefan Kluckner, Yao-Jen Chang, Terrence Chen, Benjamin S. Pollack
Abstract: Methods and kits for sampling mucous from within a sinus to determine if a single sample includes one or more bacterial types indicating a bacterial infection, such as bacterial sinusitis, and one or more viruses indicating a viral infection, such as influenza.
Type:
Grant
Filed:
April 13, 2020
Date of Patent:
May 16, 2023
Assignee:
Entvantage Diagnostics, Inc.
Inventors:
Joseph Skraba, Oriana E. Hawkins, Rebekah M. Reiser, Oscar E. Okiya
Abstract: A system and method for facilitating a cardiac rhythm disorder diagnosis with the aid of a digital computer is provided. Cutaneous action potentials of a patient are recorded over a set period of time as ECG data and a difference between recording times of successive pairs of R-wave peaks are recorded as R-R intervals. A heart rate is associated with each time difference. An R-R interval plot of the ECG data is generated. A presence of a cardiac event is displayed by presenting a presence of sinus tachycardia or a presence of bradycardia via the R-R interval plot.