EVOCAL Health Receives CE Certification For Vocal Biomarker Technology
First commercial product now CE-certified medical device
Hamburg (Germany), May 21, 2021: EVOCAL Health, a biopharmaceutical digital health company unlocking the human voice as a biomarker for respiratory, cardiovascular, and neurodegenerative diseases, today announced that its first commercial product has received CE certification as a medical device.
EVOCAL Health develops and researches technologies for AI-based detection and treatment of respiratory, cardiovascular, and neurodegenerative diseases based on vocal biomarkers. The company’s device-agnostic software application runs on casual smartphones. Vocal biomarkers have the potential to fundamentally change the diagnosis and treatment of diseases and open up novel applications with significantly better cost-benefit ratios in the future. They represent a future technology for the digitalization and democratization of healthcare worldwide.
Before a medical device can be launched in the European Economic Area (EEA), it must confirm that the medical device meets certain essential safety requirements to receive a CE mark. Within a so-called conformity assessment, manufacturers of medical devices determine the conformity of their products with the essential requirements of the European directives. The procedure requires a comprehensive conformity assessment procedure evaluating acceptable risk-benefit ratio, safety, suitability for use, and compliance with software lifecycle processes.
“We are delighted about receiving our first regulatory approval. As a manufacturer of CE-marked medical devices, we take our responsibilities seriously and have implemented company-wide quality management processes and information security systems. Our ambition is to develop products and algorithms that fulfill the highest and worldwide acknowledged medical device standards, and fulfill the high-level GDPR data privacy standards”, said Philip Mertes, CEO/COO and Co-Founder of EVOCAL Health.