FDA-cleared prescription digital therapeutics

Domain IX · Biomedical, neuro & digital · 2017 · United States

What it is

Prescription digital therapeutics (PDTs) are software medical devices that the FDA has authorised for a named condition, age group and use, and that are available only on the order of a licensed clinician. They are not a single therapy but a regulatory category: each product packages a…

Format

• This is a framework for the psychotherapist's work around a PDT course, not a protocol the manufacturers publish.
• Phase 1: Assessment and fit (one to two sessions, can sit inside ongoing therapy). Goals: confirm the diagnosis matches a cleared indication; confirm age falls within the label; screen for stated exclusions (for example, MamaLift Plus is not appropriate for severe depression or anxiety, serious…

Who practises it, and how they are trained or regulated

• Version followed: US FDA authorisations and the indication wording reported by FDA, the manufacturers and trade press between November 2020 and November 2025; regulatory status summarised as of October 2026 per the sources listed. Status of these products changes often (see Pear Therapeutics below), so re-check each product's current labelling, availability and ownership before every new prescription or referral.
• Prescription digital therapeutics (PDTs) are software medical devices that the FDA has authorised for a named condition, age group and use, and that are available only on the order of a licensed clinician. They are not a single therapy but a regulatory category: each product packages a psychological or cognitive method (CBT, CBT for insomnia, cognitive-emotional training, an attention-targeting video game, a…
• Current commercial availability of each product in October 2026 is; the table gives the last reported regulatory and ownership position, not proof that a product can be ordered today. Big Health's FAQ describes a live ordering route for SleepioRx and DaylightRx (a provider ordering website with unique patient access codes). PursueCare describes delivering reSET and reSET-O through its own programmes and partner…

Questions to explore with your client

• What drew you to it, and what are you hoping it will change?
• Does it involve any substance, plant preparation, remedy or supplement? Has your doctor or prescriber been told, especially about any medication you take?
• Is it a group, retreat or community? How do they respond if someone wants to leave or raises a concern?
• How do you and the practitioner understand what is happening, in spiritual or cultural terms? Is that a source of comfort, worry, or both?
• Does it use a device, heat, cold, water or a physical procedure? Has a medical professional checked that it is safe for you?
• Who runs it, and what training or registration do they hold?
• What actually happens in a session or meeting, and how often?
• What does it cost, and is there pressure to commit to more?
• How do you feel afterwards, in the hours and days that follow?
• Does it fit with, or clash with, the work we do here?

What practitioners of it watch for

• in-app progress that looks good while measured symptoms worsen.
• codes not received, wrong phone number, incompatible device, the client quietly never starting.
• nobody owning follow-up when the ordering clinician and therapist assume the other is monitoring.
• symptom return after the app ends; the client crediting all gains to the app and none to themselves.
• coercive control (a partner monitoring the phone); clients who later disengage because they feel watched.

When to involve someone else

• New or worsening physical symptoms, or advice to stop or change prescribed medication: involve the client's doctor or prescriber.
• Signs of coercion, isolation from family and friends, escalating costs or secrecy: discuss openly and consider safeguarding.
• A crisis or thoughts of suicide: follow your crisis protocol. In the US, call or text 988; in the UK and Ireland, Samaritans on 116 123.

Drawn automatically from the guide's own sections. Stay curious: neither endorse nor dismiss what the client values, and check anything that matters against the full guide and its sources. Not medical advice.