DGAP-News: VisionHealth GmbH / Key word(s): Miscellaneous
VisionHealth receives EU Medical Device Regulation certification
Munich (Germany), December 20, 2021 - VisionHealth GmbH, a pioneer in digital therapeutics (DTx) for the inhaled treatment of chronic lung diseases, today announced the successful certification of its quality management system according to the new EU Medical Device Regulation (MDR 2017/745) and EN ISO 13485. This certification enables VisionHealth to confirm compliance of their Kata(R) app, as well as subsequent versions, with the MDR standards based on the Company's audited quality management system.
With the regulatory change from the Medical Device Directive (MDD) to MDR, requirements for both manufacturers and notified bodies have changed significantly. The new MDR extends the needs and details for technical documentation and introduces requirements for state-of-the-art IT security.
"I would like to thank the whole team for the intensive work and tremendous effort to complete the certification in such a short time. We have worked hard to fulfill the standards for a MDR certification of our quality management. This certification allows us to advance our platform to further strengthen the benefits patients and medical professionals can take from Kata(R). Certification also proves that VisionHealth is a reliable partner and represents an important milestone on our path towards DiGA application," said Dr. Sabine Häußermann, CEO and founder of VisionHealth GmbH.
VisionHealth's DTx App Kata(R) is CE marked and a medical device class I (MDD). From the next version on, it will be classified as class IIa medical device (MDR) due to its intended use to monitor and improve inhalation therapy: The Kata(R) app guides patients suffering from chronic respiratory disease like asthma and Chronic Obstructive Pulmonary Disease (COPD) to improve their inhalation technique, leading to a better medication deposition in the lung. The execution of the inhalation process is prone to errors: studies have shown error rates between 32 and 100 %.,,,, Incorrect inhalation and the resulting underdosing of drugs cause a high unmet medical need and higher rates of complications and exacerbations in the most prevalent chronic lung diseases, Asthma and COPD. Especially in COPD, every exacerbation is known to cause an irreversible loss of lung function. Better disease control with fewer exacerbations and consequently lower hospitalization rates could lead to massive cost savings for public health systems.6 The Kata(R) app controls the therapeutic inhalation and trains the patient by providing immediate feedback through its proprietary AI-based algorithm, thus delivering the support that is needed to regularly deposit the intended dose of the drug in the lung. Worldwide, Kata(R) could support the therapy of approximately 250 million patients suffering from chronic respiratory diseases, with an estimated 8.9 million cases alone in Germany.,
A modified Kata(R) app for clinical trials (Kata(R) Clinical) combines data and patient management to enhance the participants' experience and improve study outcomes at the same time. Based on the customized adaptation to the specific needs of a study, data collection and management can be conducted more efficiently and are less error-prone due to automation.
20.12.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.