Maisense announces CE Mark Approval of ECG Atrial Fibrillation Detection for cardiovascular monitor

Maisense announces CE Mark Approval of ECG Atrial Fibrillation Detection for cardiovascular monitor

Maisense’s award winning Freescan solution (Source: © Maisense)

First all-in-one Personal Cardiovascular Monitor and AI-based Stroke Prevention to enable early detection of key factors indicating stroke risk

Hsinchu, Taiwan March 15th, 2019 – Maisense, an innovative startup, devotes itself to stroke prevention, announced today it has received CE Mark clearance for its ECG Atrial Fibrillation and Arrhythmia (Tachycardia and Bradycardia) detection. The award winning solution already received the CE Mark for cuff-less blood pressure monitoring in 2015. The approval makes Maisense’s Freescan the first CE approved cardiovascular monitor which combines cuffless blood pressure measurement and ECG Atrial Fibrillation Detection in a single measurement. Freescan is particularly user friendly while providing very precise results.

In 2015, Maisense launched Freescan, the world first pocket-sized cuff-less blood pressure monitor, with CE class II medical certification. Freescan has won several recognitions worldwide: 2016 Top 10 innovations in Arab Health Expo, and 2018 top 10 health App at MEDICA App Competition in Germany. Maisense also won the 2017 Taiwan top 10 coolest innovative startups award.

„It is a significant achievement of Freescan to obtain the CE Mark Approval for ECG Atrial Fibrillation (AFib) detection. This empowers those health-conscious individuals in Europe and other countries (which recognize CE Mark) to track the signs of cardiovascular diseases at home, because early recognition is key to reducing the risk for strokes and other cardiovascular diseases,“ said Bach Chen, CEO of Maisense.

According to World Health Organization (WHO)“s report in May 2018, stroke is the second leading cause of deaths globally after ischemic heart disease. Of the 56.9 million deaths in 2016, almost 6 million died in stroke, about 10% of all deaths. Since up to 80% of stroke are preventable, „It is Maisense“s mission to help people to enjoy better quality of life. We started with stroke prevention by detecting the top 3 risk factors of stroke-arterial stiffness, atrial fibrillation and hypertension,“ said Andrew Chang, chairman of Maisense.

Not only does Maisense improve the processes of measurement through the pocket-sized „Freescan“ device, but it also enables individuals to easily manage their own health by monitoring and analyzing their own vital signs using the intelligent „myFreescan“ App. Users can observe many features on myFreescan, such as trend view for historical blood pressure measurements, rPWV (radial pulse wave velocity for arterial stiffness), AFib/ arrhythmia screening, and ECG/pulse waveform viewing.
Freescan“s clinical validation on AFib detection was finished in the Chang-Gung Memorial Hospital, Keelung, Taiwan with sensitivity of 96.72% and specificity of 99.06%. The result will be presented at EHRA (European Heart Rhythm Association) in Lisbon, Portugal on March 17th~ 19th 2019 by the topic „Clinical Validation of a Portable Cardiovascular monitor for Atrial Fibrillation Detection“.

Maisense is also growing its channel and is actively looking for distributors in the European Union. In Germany, Maisense is excited to have formed a partnership with the well renowned TITAN Commerce and appPeople. TITAN Commerce is a leading distributor for Bio-/Neurofeedback, sportswear technology and wearables based in Germany. appPeople provides worldwide progressive impulses in the field of telemedicine. Freescan is also available in Germany at Mindtec ( https://goo.gl/VmBsR7) and ME Health CHECK ( https://goo.gl/JGZjZo).

About TITAN Commerce
TITAN Commerce“s wide product range includes state-of-the-art biotechnology, wearables and professional Sportswear technologies from various well-known biofeedback, neurofeedback and wearable manufacturers. The goal of TITAN Commerce is to provide end-customer with the most technically innovative products to help them to deal with their daily impact of external influences such as stress, exhaustion, concentration and attention deficits. For more information, please visit: http://www.titan-commerce.com/de/

About appPeople
Founded in 2011, appPeople GmbH develops and distributes mobile applications and medical devices. The innovative products enable the regular collection of relevant health parameters, helping to better assess treatment outcomes and improve users‘ quality of life. The dynamically growing company works with partners in Europe and Asia and is one of the most successful and creative names in its field. For more information, please visit: http://www.apppeople.de/en/start.html

About Maisense:
Maisense is an innovative startup engaging in non-invasive cardiovascular monitor for personal use and artificial intelligence software for stroke prevention including AFib/arrhythmia/artery stiffness detection for professional physician use. Founded in 2012, Maisense was granted the award for „Best Investment Potential“ by Taiwan“s Ministry of Economic Affairs. Maisense“s Freescan is the world first cuff-less blood pressure monitor measuring directly from wrist pulse and it has received EU CE medical certification. It has been honored with the 2015 National Innovation Award in Taiwan, as well as ranking second among the Top 10 Innovative Health Products at the Arab Health 2016 fair in Dubai. In 2017, it has received the „Taiwan top 10 coolest innovative startups award“ from the Ministry of Science and Tech in Taiwan. For more information, visit www.maisense.com

Company-Contact
Pressoffice Maisense
Wibke Sonderkamp
Münchner Str. 14
85748 Garching bei München
Phone: +49.89.360363.40
E-Mail: wibke@gcpr.net
Url: http://www.maisense.com/en/

Press
Pressoffice Maisense
Laura Lehmann
Münchner Str. 14
85748 Garching bei München
Phone: +49.89.360363.52
E-Mail: laura@gcpr.net
Url: https://www.gcpr.de/

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