Worldwide unique health app Kata® receives CE certification as a medical device

 

  • Paving the way for admission to standard care in Germany
  • High savings potential for health insurances and the health sector
  • Accelerating new quality of care for an estimated 8.4 million respiratory patients in Germany

 

Garching, 18. November 2019 – VisionHealth GmbH announces the certification of its health app “Kata®” as a medical device. Experts predict that with this digital therapy assistance, more than 250 million chronically ill respiratory patients worldwide will be able to use their inhalers more effectively, improve their treatment and improve their quality of life. Savings in the millions are expected in the healthcare sector.

Paving the way for admission to standard care in Germany

With the Europe-wide certification as a medical device, an elementary step has been taken for the German market towards inclusion in standard care in accordance with the new “Digital Health Care Act” (Digitales Versorgungsgesetz). As a development specialist for highly innovative, digital health solutions for respiratory indications, VisionHealth is thus paving the way for a new quality of treatment for an estimated 8.9 million respiratory patients in Germany [1],[2]. Sabine Häußermann, CEO of Vision Health GmbH, emphasizes: “Now there is nothing standing in the way of cooperation with health insurance companies in Germany.”

Kata® as a digital medical device: far more than conventional lifestyle apps

“The certification is a clear seal of quality for us,” says Häußermann. “In the rapidly growing market for health apps, Kata® now belongs to the less than one percent certified as a medical device[3].“ Thus VisionHealth strongly differentiates its digital health solution from conventional lifestyle apps.

Enormous savings potential for the healthcare market

The health costs for asthma and COPD (Chronic Obstructive Pulmonary Disease) already amounted to 250 billion dollars worldwide in 2015[4], and rising. Of this, $164 billion alone is spent annually on the consequences of incorrect use of inhalers[5]. „Studies have shown that improved handling of inhalation systems can significantly improve therapeutic success.[6],[7],[8]“, erklärt Philipp Kroneberg, COO of VisionHealth. “With Kata®, patient well-being is always our number one priority. In addition, there are significant financial benefits that we from VisionHealth offer to health insurance companies and the entire healthcare sector with our digital therapy enhancement. Savings in the millions are to be expected.”

About VisionHealth

VisionHealth is a German enterprise located in Garching near Munich. There, experts from medicine and IT develop innovative digital health solutions in cooperation with research institutions, which in a networked world enable real progress and improvement of therapy standards for patients.

www.visionhealth.gmbh | www.kata-inhalation.com


VisionHealth CEO Sabine Häußermann (high-resolution image)


Health app Kata® is now a certified medical product (high-resolution image)


VisionHealth COO Philipp Kroneberg (high-resolution image)

[1] RKI.. 12-Monats-Prävalenz der bekannten chronisch obstruktiven Lungenerkrankung (COPD) in Deutschland. https://doi.org/10.17886/RKI-GBE-2017-053
[2] RKI.. 12-Monats-Prävalenz von Asthma bronchiale bei Erwachsenen in Deutschland. https://doi.org/10.17886/RKI-GBE-2017-052
[3] Kramer, U., Borges, U., Fischer, F., Hoffmann, W., Pobiruchin, M. & Vollmar, H. C. (2019). DNVF-Memorandum – Gesundheits- und Medizin-Apps (GuMAs). Gesundheitswesen (Bundesverband der Ärzte des Öffentlichen Gesundheitsdienstes (Germany)), 81(10), e154-e170. https://doi.org/10.1055/s-0038-1667451
[4] ERS Whitebook 2017
[5] Roggeri A et al.International Journal of COPD 2016:11 597–602
[6] Morton RW, Elphick HE, Rigby AS, et al. (2017). STAAR: a randomised controlled trial of electronic adherence monitoring with reminder alarms and feedback to improve clinical outcomes for children with asthma Thorax 2017;72:347-354.
[7] Chan, Amy H. Y.; Stewart, Alistair W.; Harrison, Jeff; Camargo, Carlos A.; Black, Peter N.; Mitchell, Edwin A. (2015): The effect of an electronic monitoring device with audiovisual reminder function on adherence to inhaled corticosteroids and school attendance in children with asthma: a randomised controlled trial. In: The Lancet Respiratory Medicine 3 (3), S. 210-219. DOI: 10.1016/S2213-2600(15)00008-9.
[8] Jardim, J. R. & Nascimento, O. A. (2019). The Importance of Inhaler Adherence to Prevent COPD Exacerbations. Medical Sciences (Basel, Switzerland), 7(4). https://doi.org/10.3390/medsci7040054