Noah Labs is thrilled to announce that our telemonitoring software, Noah Labs Ark, has secured Class IIa medical device approval under the European Union Medical Device Regulation (MDR), paving the way for advanced cardiovascular diseases management.
We have reached a significant milestone: our digital medical device "Noah Labs Ark" has received approval as a Class IIa medical device. This means that the quality, safety and effectiveness of our software has been officially confirmed and it can now be used regularly in medical practices for telemonitoring cardiovascular diseases and other conditions. So far, Noah Labs Ark has been piloted in numerous cardiology and GP practices in Europe.
How Noah Labs Ark is closing the gap
Very few people record their vital signs, symptoms and biomarkers in a structured way between visits to the doctor's office or hospital. In addition, few patients receive regular support to manage their condition, and it can take months to get an appointment with a cardiologist. Noah Labs fills this gap in care by providing a tool for remote monitoring and support for patients with hypertension, arrhythmia, heart attacks or heart failure.
Dr. Leonhard Riehle, medical doctor and co-founder of Noah Labs: “We are delighted and very proud to have received medical approval for Noah Labs Ark in less than a year. This shows that our research with artificial intelligence has been excellent. The feedback from the participating medical practices also confirms that we have filled a gap in the healthcare system with our software-based monitoring solution. Above all, we want to make a lasting improvement in the quality of patient care and enable people with cardiovascular disease to live longer and healthier lives. We have now taken a major step towards achieving this goal.”
Taking patient care to the next level: How Noah Labs Ark works
Noah Labs Ark enables comprehensive remote monitoring and support of chronic diseases by monitoring relevant vital parameters to assess and predict patient health. The current cardiology application focuses on heart failure and can also monitor hypertension and arrhythmias. Smartwatches, ECGs and blood pressure monitors that are approved as medical devices transmit the data collected from the patient in real time to the doctor's office or clinic. This enables doctors to identify deterioration and risk at an early stage. This has been shown to reduce cardiovascular events, hospitalisations and mortality, for example in heart failure. In addition, the highly accurate and reliable data set reduces false alarms. This enables safe, guideline-based care and provides the basis for seamless cardiovascular disease management.
How Noah Labs Ark makes medical practices more efficient
With the use of Noah Labs Ark, full waiting rooms with chronically ill patients are a thing of the past. Practices and clinics can keep an eye on patients at all times via an intelligent dashboard with automatic notifications. The software is designed so intuitively that the majority of daily tasks can be carried out by the practice team. Depending on the number of patients included, the total time required is around 10-15 minutes per day. In addition, the availability of doctors is clearly regulated.
Another benefit is the extra-budgetary remuneration available in Germany. This is because the use of telemonitoring can be billed per patient to statutory and private health insurers in accordance with the standardized assessment scale (EBM). The Noah Labs team takes care of setting up all devices and technical aspects. Training is also included in the service package. Doctors can therefore focus on treating their patients.
Cardiovascular diseases are the number 1 cause of death
340,619 people died from cardiovascular disease in Germany in 2021. This means that cardiovascular diseases are still the number one cause of death. They cost around 46.4 billion euros a year. In addition to genetic causes and unhealthy lifestyles, a lack of early detection and inadequate monitoring and care are the main reasons for these high figures. Most cardiovascular diseases sooner or later lead to a weakening of the heart muscle, known as heart failure, which affects around 3 million people in Germany. Noah Labs' vision is to significantly reduce these figures.
About Noah Labs
Noah Labs is a Berlin-based digital health startup. Founded in 2021 by Oliver Weiss, Marcus Hott and Dr. Leonhard Riehle, the company aims to help people with cardiovascular disease live longer and healthier lives. Marcus Hott previously worked as an AI programmer at Harvard Medical School, while Oliver Weiss, who studied economics, founded the elderly care company Mecasa before founding Noah Labs. Dr. Leonhard Riehle is a medical doctor who previously worked in the field of cardiovascular telemonitoring at the Charité in Berlin. Noah Labs has 15 employees and is ISO 13485 certified as a manufacturer of (software-based) medical devices.
Noah Labs is currently conducting a groundbreaking clinical study to investigate the potential of voice analysis as a non-invasive and early biomarker for the diagnosis and monitoring of patients with heart failure. The study, which is being conducted at the German Heart Centre (DHZC) of the Charité in Berlin, Germany, aims to provide new insights into the clinical application and efficacy of voice analysis as a novel diagnostic tool in the management of chronic heart failure. In the future, such a solution could help guide therapeutic decisions and reduce the risk of cardiac decompensation.
Noah Labs is also collaborating with UMC-Maastricht and the Barcelona Clinic for clinical studies. The start-up is funded by EIT Health and the state of Berlin. Noah Labs is also a member of the American Heart Association's Centre for Health Technology & Innovation.
Further information:
For cardiologists: https://www.noah-labs.com/kardiologen
For general practitioners: https://www.noah-labs.com/hausaerzte
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