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-O is an iOS application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as an adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433019 ()


  • Mental health/function therapeutic software, screen-viewed
RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433002 ()


  • Mental health/function therapeutic software, screen-viewed
SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.
Big Health Inc.
v1
In Commercial Distribution

  • 00860008033024 ()


  • Mental health/function therapeutic software, screen-viewed
Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0003-001
In Commercial Distribution

  • 00860006172015 ()
01-0003-001

  • 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
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
ODXTT UG & ADF V10.0 USB - USA
LIFE TECHNOLOGIES CORPORATION
A51694
In Commercial Distribution

  • 10190302017756 ()


  • 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
Personal Genome Service - Carrier Status Reports
23ANDME, INC.
YouDot (Carrier)
Not in Commercial Distribution

  • 00862150000060 ()


  • Human genomic analysis interpretive software
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms. Somryst uses sleep restriction and consolidation, limiting the time a patient spends in bed to match the amount of time they sleep. This treatment technique can increase risks to some patients whose pathophysiology may be worsened. Because of this, it is not appropriate for everyone.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008255 ()
  • 96439-0030-01 ()


  • Mental health/function therapeutic software, screen-viewed
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