SEARCH RESULTS FOR: ("Oregon Health")(377403 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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"reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:  · increase abstinence from a patient’s substances of abuse during treatment, and · increase retention in the outpatient treatment program."
PEAR THERAPEUTICS, INC.
1.4.6
Not in Commercial Distribution

  • 10851580008019 ()


  • Mental health/function therapeutic software, screen-viewed
ODXTT UG AND ADF 1.8 - US
LIFE TECHNOLOGIES CORPORATION
A32461
In Commercial Distribution

  • 10190302006071 ()


  • Human genomic analysis interpretive software
ODXTT UG & ADF V3.6 USB-US
LIFE TECHNOLOGIES CORPORATION
A49678
In Commercial Distribution

  • 10190302015646 ()


  • Human genomic analysis interpretive software
ODXTT UG & ADF V10.0 USB - USA
LIFE TECHNOLOGIES CORPORATION
A51694
In Commercial Distribution

  • 10190302017756 ()


  • Human genomic analysis interpretive software
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. The EndeavorRx program is software-as-medical device (SaMD) that resides on the user’s mobile device and can be executed at home. EndeavorRx is engineered as a therapeutically active treatment for attention in pediatric patients affected by ADHD. EndeavorRx is built on Akili’s proprietary, patented, technology platform which is designed for the selective targeting and modulation of specific cognitive neural systems in the brain related to attention function. EndeavorRx uses Akili’s adaptive algorithms (also known as Selective Stimulus Management Engine, SSME™) to deliver the presentation of stimuli that are designed to engage targeted neural systems which play a key role in attention function. In a closed-loop system, the adaptive SSME algorithms automatically adjust the difficulty level for a personalized treatment experience that is tailored to the needs of each individual patient. EndeavorRx is delivered through a video game experience which leverages art, music, storytelling, and reward cycles to keep patients engaged. The adaptive algorithm constantly pushes patients precisely at predefined performance bounds relative to each individual, such that they are continuously encouraged to exceed their historic performance.
AKILI INTERACTIVE LABS, INC.
Treatment 1
In Commercial Distribution

  • 00850002639018 ()
50002063901

  • Mental health/function therapeutic software, screen-viewed
Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.
CliniSys, Inc
6.3
Not in Commercial Distribution

  • B236SMG6300 ()


  • Human genomic analysis interpretive software
The AT-910 ("A10tion") is a is a virtual reality, immersive therapeutic application, indicated to train and improve cognitive function of patients with diagnosed ADHD. This application is a clinician- monitored program and should be considered for use as part of the therapeutic program that include clinician directed therapy This multidimensional training program application targets attention, executive function and memory combined with motor activation through the use of games and entertainment features.
XR HEALTH IL LTD
AT-910 (A10tion)
Not in Commercial Distribution

  • 07290016986143 ()
VRCBT AT-910

  • Mental health/function therapeutic software, screen-viewed
A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-620 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-620 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.
XR HEALTH IL LTD
CT-620 (Memorize)
In Commercial Distribution

  • 07290016986112 ()


  • Mental health/function therapeutic software, screen-viewed
A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-610 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-610 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.
XR HEALTH IL LTD
CT-610 (Re-Act)
In Commercial Distribution

  • 07290016986105 ()


  • Mental health/function therapeutic software, screen-viewed
The CB-510 ("Luna") is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and supporting exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The CB-510 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The CB-510 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. CB-510 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
CB-510 (Luna)
In Commercial Distribution

  • 07290016986068 ()


  • Mental health/function therapeutic software, screen-viewed
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