Prescribed software: three routes to a therapeutic app, in the regulators' words

Digital therapeutics share a category, not a kind of record. This article sets three routes side by side, each quoted from the regulator's or the government's own page: a Japanese marketing approval for CureApp's apps, a United States 510(k) clearance for Hinge Health's Enso for Migraine, and an agreement between Portugal's national health service and Sword Health. Natural Cycles, a cleared consumer app, is a fourth case for contrast. Company statements are marked as the company's. Recent has not used or tested any of these products, and nothing here is clinical advice.

Three routes at a glance

Japan: approval on the regulator's review record

The Ministry of Health, Labour and Welfare's administrative notice of 26 April 2022 lists CureApp HT among devices "新医療機器として承認された" (approved as new medical devices), with approval number 30400BZX00100000 and the generic name "高血圧症治療補助プログラム" (a programme assisting hypertension treatment). The PMDA's review report, in an English translation that says "the Japanese original shall take precedence", gives the intended use as "Adjunctive treatment of essential hypertension in adults".

The report records what CureApp had to show. The HERB trial was "a prospective, multicenter, parallel-group, controlled-study"; its primary endpoint was the "change in mean 24-hour ambulatory systolic blood pressure from baseline to Week 12", and the between-group difference was minus 2.4 mmHg (95% CI, minus 4.5 to minus 0.3 mmHg; the report's minus signs are written out here). The approval carries a condition:

For CureApp SC, the PMDA list gives its approval as August 2020. Its review report describes a randomised study "in 584 subjects at 31 study centers in Japan" in which the continuous abstinence rate from weeks 9 to 24 "was 63.9% in the CASC group and 50.5% in the control group". It is explicit about access: "The CASC system is available only on a physician's prescription."

Payment is where the sources change from regulator to company. CureApp's HT product page states the insurance items billed from June 2024: a management fee of 90 points (in-person), a first-month add-on of 50 points, and a specified insurance medical material at 7,010 yen, once a month for up to six months. CureApp's notice of 1 June 2026 says that, under that year's fee revision, a rate of 78 points was added for management by online consultation, beside the 90 points for in-person consultation, and that the add-on and the material price are unchanged. Its product index says HT went on sale and was insurance-listed on 1 September 2022 ("2022/9/1発売・保険収載"). These are the company's statements of the fee schedule; the Ministry's fee-schedule notice was not read for this article.

United States: clearance by substantial equivalence

The FDA's record for K254216 lists Enso for Migraine from Hinge Health, Inc., with the decision "Substantially Equivalent (SESE)" on 16 April 2026. The decision letter says the FDA has "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This is a clearance, not an approval, and the letter adds that the determination "does not mean that FDA has made a determination that your device complies with other requirements of the Act". The predicate is K234029, CEFALY Connected OTC (a dash in that name is re-punctuated here).

The 510(k) summary describes "an over-the-counter medical device", a TENS unit "controlled wirelessly using the Hinge Health mobile application". What had to be shown differs from Japan: "Clinical performance testing was not conducted for the subject device. Instead, clinical effectiveness and safety were established via analysis of published clinical literature for the legally marketed predicate device."

The payer sits outside the regulator's record. Hinge Health's release of 29 April 2026 introduced a Migraine Care Program and says that "more than 125 clients covering more than two million people" have adopted it, which the company reads as a sign "that employers are ready to act". The release states no price.

Portugal: a public system's agreement

The Government of Portugal's page (published 19 June 2026, updated 24 June) says the Minister of Health and the Minister for State Reform (Ministro Adjunto e da Reforma do Estado) attended, on 18 June, the presentation of the "convenção" (agreement) between the SNS and "a empresa portuguesa Sword Health". In the government's words, the solution lets "médicos do SNS prescrevam programas de fisioterapia remota" (SNS doctors prescribe remote physiotherapy programmes) for common musculoskeletal conditions, "através de um dispositivo médico certificado" (through a certified medical device), "sem custos para os utentes". After the prescription, each person has an initial assessment with a team of physiatrists and physiotherapists and receives the equipment at home. The measure follows Despacho n.º 1211/2026, which admitted telerehabilitation with certified medical devices into the SNS.

The page's figures are estimates, and it says so: "Estima-se" (it is estimated) that the technology could cut the wait to start treatment by 97% and save around 45% against conventional physiotherapy. They are projections, not outcomes. The page's photograph caption dates the occasion 18 May 2026; its text says 18 June.

In the United States, Sword's record is of a different kind. The FDA's registration and listing database lists "Sword Thrive" and "Digital Therapist" under product code ISD, "Exerciser, Measuring", Class 2, with Sword Health S.A. as owner and operator. A registration and listing is not a clearance, and openFDA's 510(k) database returns no match for an applicant named "sword". The government page does not name the product used in Portugal, so these records do not establish that the SNS solution is Thrive.

A fourth case: cleared software its user starts

Natural Cycles holds six FDA records under product code PYT: the first a De Novo record, DEN170052 (August 2018), and the latest a 510(k) clearance, K253694, on 17 July 2026. The summary describes "an over-the-counter and prescription web and mobile-based standalone software application", and its predicate is the company's own earlier clearance, K231274. On this route, by the summary's own description, use does not depend on a prescription.

Recent analysis: what "prescribed" changes on the screen

This is Recent's reading of the records above, not a finding about how the products perform.

Onboarding. Where a prescription is required, it becomes an object in the software. CureApp's SC site describes a flow in which CureApp's prescribing platform issues a 処方コード (prescription code) and the patient enters it in the app. Portugal's page puts a clinical assessment before any equipment arrives. Enso's indications assume a physician's diagnosis, but the device is over the counter, and the FDA record does not describe how, or whether, the app asks about that diagnosis.

Adherence and escalation. The PMDA report ties continued use to continued care: "The patient app is locked if the patient does not receive a medical consultation from their treating physician for an extended period of time." The Portuguese page describes monitoring "sob supervisão permanente de profissionais de saúde" (under the permanent supervision of health professionals). The FDA record for Enso says nothing about supervision; that belongs to the programme, which only the company describes.

Evidence. The three routes asked different questions. Japan asked for a controlled trial of the app itself and an annual report that its efficacy holds. The FDA asked whether the device is substantially equivalent to a predicate, with clinical support drawn from the predicate's literature. Portugal made a purchasing decision whose savings it estimates. "Prescribed", "approved" and "FDA-cleared" on a product page each name a route, not a result.