VISIONHEALTH

DGAP-News: VisionHealth's Kata Clinical to be included into Alcedis service platform for clinical studies

Retrieved on: 
화요일, 2월 1, 2022

"We are delighted to win Alcedis as a strong partner for data-driven clinical trials in respiratory diseases.

Key Points: 
  • "We are delighted to win Alcedis as a strong partner for data-driven clinical trials in respiratory diseases.
  • The technology of Alcedis service platform brings together science, technology and innovation to offer customized concepts for highly qualitative studies," said Dr. Sabine Huermann, CEO and founder of VisionHealth GmbH.
  • Therefore, we are excited to work with VisionHealth and be able to include Kata(R) Clinical into our service platform," Hanno Hrtlein, Managing Director of Alcedis, commented.
  • Kata(R) Clinical complies with the criteria of good clinical praxis (GCP) and meets all technical, regulatory and data protection regulations, qualifying it for the use in clinical studies.

DGAP-News: VisionHealth receives EU Medical Device Regulation certification

Retrieved on: 
월요일, 12월 20, 2021

MDR certification prerequisite to enhance, further develop and release future Kata(R) versions

Key Points: 
  • MDR certification prerequisite to enhance, further develop and release future Kata(R) versions
    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.
  • With the regulatory change from the Medical Device Directive (MDD) to MDR, requirements for both manufacturers and notified bodies have changed significantly.
  • 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 Huermann, CEO and founder of VisionHealth GmbH.

DGAP-News: VisionHealth's Kata(R) Clinical app to support sterna biologicals' clinical Phase IIa asthma trial

Retrieved on: 
화요일, 11월 23, 2021

Kottmann GmbH & Co. KG, a Clinical Research Organization (CRO) that will apply Kata(R) Clinical also beyond this trial.

Key Points: 
  • Kottmann GmbH & Co. KG, a Clinical Research Organization (CRO) that will apply Kata(R) Clinical also beyond this trial.
  • Kata(R) Clinical is a modified Kata(R) app for Clinical Trials from VisionHealth's artificial intelligence proprietary platform for inhalation therapy support.
  • The App is offered to pharma, biotech and CRO partners to support clinical trials in the respiratory field.
  • For sterna's asthma trial, VisionHealth adapted Kata(R) Clinical to specifically support the run-in period for patient preparation and therapy adherence, ensuring the correctly performed inhalation with SB010.

DGAP-News: VisionHealth adds Clinical Trial Function to Kata App supporting and optimizing inhalation therapy of chronic lung diseases

Retrieved on: 
목요일, 11월 4, 2021

The newly launched Kata(R) Clinical allows remote collection of high-quality data, including clinical parameters and conditions.

Key Points: 
  • The newly launched Kata(R) Clinical allows remote collection of high-quality data, including clinical parameters and conditions.
  • The Kata(R) platform builds on VisionHealth's proprietary artificial intelligence (AI) algorithm to monitor and support correct inhalator usage for the therapy of chronic lung diseases.
  • The aim of the Kata(R) app for patients is to optimize the drug inhalation therapy of chronic lung diseases through digital support.
  • 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.