isi PMS App

DiGA App for Prämenstruelle Beschwerden · provisionally listed

isi PMS App App at a Glance

Short Description

🇩🇪 Legally binding original Rechtsverbindliches Original · BfArM

Die isi-App wurde von der Endo Health GmbH entwickelt und 2024 unter der Basis 426071973ISIJ7 als Medizinprodukt der Risikoklasse 1 zugelassen. Wie in der medizinischen Zweckbestimmung beschrieben, unterstützt die „Smartphone-Anwendung isi-App […] PMS-Betroffene durch evidenzbasierte und leitlinienkonforme Inhalte, Methoden und Übungen der multimodalen Schmerztherapie und PMS-Therapie“. Die isi-App richtet sich an alle Betroffenen mit PMS, die mindestens 18 Jahre alt sind. Allgemeine Kontraindikationen werden nicht angegeben. Die isi-App ist eine Smartphone-Anwendung, die Betroffenen multimodale Selbstmanagement-Strategien vermittelt und als Begleittherapie zu anderen Therapien im Rahmen der Standardversorgung eingesetzt werden kann. Zudem kann die isi-App im Rahmen der Tertiären Prävention einer weiteren Verschlechterung der Symptome und Lebensqualität vorbeugen.

🇬🇧 English translation automatically translated

The isi app was developed by Endo Health GmbH and approved in 2024 under the basis 426071973ISIJ7 as a class 1 medical device. As described in the intended medical purpose, the "smartphone application isi app [...] supports those affected by PMS through evidence-based and guideline-compliant content, methods, and exercises of multimodal pain therapy and PMS therapy." The isi app is intended for all individuals affected by PMS who are at least 18 years old. No general contraindications are specified. The isi app is a smartphone application that provides those affected with multimodal self-management strategies and can be used as an adjunctive therapy to other therapies within the framework of standard care. In addition, the isi app can be used within the framework of tertiary prevention to prevent further deterioration of symptoms and quality of life.

Automatically translated for informational purposes · Source: BfArM· Updated 8/10/2026

Category

Urogenital

Indicated for

Prämenstruelle Beschwerden

Manufacturer

Endo Health GmbH, Deutschland

Listed Since

2026-08-10 - provisionally listed

What are the experiences with the isi PMS App app?

Google Play Store

4.4 · 34 ratings

Help and Support for the isi PMS App App

Details

Indicated for ICD-10

N94.3

Contraindications

According to the manufacturer, there are no medical contraindications per ICD-10 for this DiGA.

Prescription Period

90 days

PZN

21015112

How much does the isi PMS App app cost?

Free for patients

Health insurance cost: 598.95 EUR for 90 days

Medical Device Risk Class

Risk class I under MDR

Last changed (BfArM)

8/10/2026

Age Group

Adults between 18 and 65 years

Additional Devices

none

Languages

German

Where can I find the isi PMS App app?

FAQ

Find all the answers to your questions about the isi PMS App app here.