isi PMS App
DiGA App for Prämenstruelle Beschwerden · provisionally listed
isi PMS App App at a Glance
Short Description
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.
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
Manufacturer
Endo Health GmbH, Deutschland
Listed Since
2026-08-10 - provisionally listed
What are the experiences with the isi PMS App app?
Help and Support for the isi PMS App App
Support Website
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