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| Product | Model | Company | Device type |
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| Product | Model | Company | Device type |
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Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
| Product | Model | Company | Device type |
|---|---|---|---|
| Mahana IBSMahana Therapeutics, Inc.Mental health/function therapeutic software, screen-viewed | 01-0003-001 | Mahana Therapeutics, Inc. | Mental health/function therapeutic software, screen-viewed |
| Parallel(TM)Mahana Therapeutics, Inc.Mindfulness/behavioural therapy software, non-clinician-consultative | 01-0001-001 | Mahana Therapeutics, Inc. | Mindfulness/behavioural therapy software, non-clinician-consultative |
| SleepioRxBig Health Inc.Mental health/function therapeutic software, screen-viewed | v1 | Big Health Inc. | Mental health/function therapeutic software, screen-viewed |
| reSET®Pear Therapeutics, Inc.Mental health/function therapeutic software, screen-viewed | 1 | Pear Therapeutics, Inc. | Mental health/function therapeutic software, screen-viewed |