Brief · Use case · Innovation
Prescription DTx Field Scan.
LiveScanTake stock of prescription digital therapeutics cleared or authorized in the US and EU for chronic conditions, grouped by purpose, with the boundary stated.
Prescription DTx Field Scan is a ready-made use case for Innovation. It ships under the Scan template.
For digital health and corporate development leads. You get the boundary and method first, each product with its category and maturity, how the field divides and what the scan did not look at. Items are cited or marked as gaps, and nothing is ranked.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
Which prescription digital therapeutics have been cleared or authorized in the United States and the European Union for chronic conditions, within a stated boundary?
What is scanned
Clearance and listing leave records in different places on each side of the Atlantic. The scan searches the official records and says which ones it could not search.
| Source | What it holds | What the scan does with it |
|---|---|---|
| FDA 510(k) records | Software treatments cleared under a product code, with the applicant, the decision date and the regulation number. For example, FDA’s record K191716 shows Somryst cleared on 23 March 2020 and K233577 shows Sleepio cleared on 5 August 2024, both under product code QVO.2,3 | Lists each clearance as a row with its number and date. |
| FDA De Novo records | Software treatments authorized through the De Novo route, where no predicate existed.5 | Lists them as separate rows and notes that a granted De Novo can become a predicate. |
| The German DiGA directory | Digital health applications listed for reimbursement through the BfArM’s fast track, either provisionally or permanently.4 | Lists each application with its listing status. |
| Other EU routes | Software with a medical purpose that is a medical device in the EU, which may be marketed without a reimbursement listing. | The scan says what it could and could not find for the EU outside Germany. |
What the scan does
Categories as the field defines them. The Digital Therapeutics Alliance describes a digital therapeutic as clinically evaluated software that delivers medical treatment directly to patients, in three categories: to treat, to manage or to prevent a disease, which includes directly improving a health function. The scan uses those categories to group the items and says where a product falls between them.1
Records, not press releases. A clearance is an FDA record with a number and a date. A listing is a BfArM entry. The scan lists items from those records, and an item known only from a company announcement is marked as such.2,3,4
Maturity, as analyst judgment. Each item carries one of three labels, Established, Emerging or Weak signal, and the labels are judgment and not measurement.
How it was run. At Comprehensive length the scan reports the records it searched, the date, the terms and how many items it found against how many it kept, so another analyst can repeat it.
Recommended length
Comprehensive
Records on two continents are searched, so the method has to be auditable. Comprehensive adds the account of how the scan was run and what stands out.
You can pick another length on the form. The other two stay available.
Assumptions the scan checks
The scan states the assumptions its boundary and its sources rest on, and the closing section says what they leave out. Examples for this subject:
- The product codes searched cover the products the field would call prescription digital therapeutics.
- A DiGA listing counts as an authorization for the purpose of the scan, and the scan says so.
- The records are current on the date of the scan.
Standards, guidance and sources
Definition and categories
- Digital Therapeutics Alliance, Understanding DTx: clinically evaluated software that delivers medical treatment; categories to treat, manage or prevent a disease.1
Primary records
The decision practice behind the memo itself is on the template page.
What gets flagged
Any item known only from a company announcement, any product whose record could not be found, and any difference between a clearance, a listing and an authorization.
What arrives
- Scope and boundary
- How the scan was run
- What is out there
- How the field divides
- What stands out
- What this does not cover
What it will not do
It does not rank or score the items it finds, and it does not recommend one. A scan lists what exists; when you need a view on it, run a Comparison or a Decision Memo on the items you choose.
It is not a market-size estimate. It lists products, not sales or users.
It does not rank or score the items. A scan says what exists; it does not say which item is preferable.
It is a snapshot of one date. It does not monitor the field after that date.
It lists what it could find in the sources it names. Items in sources it could not open are listed as not covered.
References
- [1] Digital Therapeutics Alliance. Understanding DTx. Read on 9 October 2026.
- [2] U.S. Food and Drug Administration. 510(k) premarket notification K191716, Somryst, Pear Therapeutics, Inc. Decision date 23 March 2020. Read on 9 October 2026.
- [3] U.S. Food and Drug Administration. 510(k) premarket notification K233577, Sleepio, Big Health, Inc. Decision date 5 August 2024. Read on 9 October 2026.
- [4] Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6, 10 December 2025.
- [5] U.S. Food and Drug Administration. Device Classification Under Section 513(f)(2) (De Novo). Found by search; the database page was not read.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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