German medtech pioneer 24sens has received EU approval for their digital heart belt smartcorCONTROL as a medical product. The EU certificates were awarded on December 29, 2023, which means that the conditions for production and sales in the EU are met, and international expansion is set to begin, starting with Austria, Germany and Switzerland.
smartcorCONTROL is an AI-based software and wearable heart monitor. The chest strap is an innovation that combines smart textiles with artificially intelligent software, making it ideal for long-term recording 24/7. In addition, the AI-based software enables the interaction of the patient’s risk factors in its analysis for more accurate data reporting. This technology makes the heart belt massively advantageous as compared to conventional ECG examinations or short-term measurements via mobile devices.
It’s estimated that roughly 33 million people suffer from atrial fibrillation. There are over five million new cases worldwide every year. People over 40, in particular, have higher risk of atrial fibrillation, especially if they also have other pre-existing conditions that work as risk factors, such as diabetes, obesity or high blood pressure. In the EU, 55 per cent of the population is 40 years or older; in the USA, every second resident is in this age group.
“The significant danger is that, in many cases, atrial fibrillation is asymptomatic and very difficult to detect, but at the same time, it is the leading cause of stroke and severe heart disease. This is precisely where Günter Grabher’s brilliant textile empire comes in: The digital heart belt provides the data before the symptoms become noticeable, thereby enabling early medical treatment,” said Rajat Khare, Managing Director of 24sens, to the UN.
The production of this life-saving heart belt is in Lustenau, Austria is going to create over 50 new jobs in the city by the end of 2025. With EU approval as a medical product, the heart belt can now be used in medical practice and sold internationally. Collaborations with doctors, hospitals and care facilities are already underway.
The textile sensor technology provides doctors with consistent, precise recording of heart data. Grabher and Khare, the two founders and owners of the start-up, see massive potential for the digital heart belt. According to the European Society of Cardiology, it’s estimated that 8.2 million people in the EU and according to the National Institute of Health, 7.3 million people in the USA suffer from atrial fibrillation. EU Medical Device Regulation places strict requirements on medical device manufacturers; numerous tests and certifications must be completed before the EU gives the green light.
“The specialists at 24sens worked intensively towards this significant goal. Approval as a medical product in the EU is the prerequisite for us to be now able to produce and sell the smartcorCONTROL heart belt in the EU,” says Grabher, cofounder of 24sens. With two official certificates awarded to the company, one for the medical product and one for quality management, the team is now gearing up for new market entry. To spearhead expansion, Managing Director, Rajat Khare has also invested around 1.5 million euros in the development, implementation and market entry in the DACH region of smartcorCONTROL and is already working on further advancing the technology.
About 24sens”
24sens is a pioneering German medtech company dedicated to revolutionizing healthcare through innovative technology solutions. Their mission is to develop cutting-edge medical devices and software that empower individuals and healthcare professionals to monitor and manage health more effectively. With a focus on cardiac health, 24sens has developed smartcorCONTROL, enabling early detection of cardiac conditions such as atrial fibrillation, leading to timely medical intervention and improved patient outcomes.
For more information about 24sens and our innovative products, please visit www.24sens.com
Media Contact
Organization: 24sens
Contact Person: Nisheta Sachdev
Website: https://24sens.com/
Email: office@24sens.at
City: Lustenau
Country: Austria
Release Id: 1902249873