Biospectal, the remote monitoring and biosensing software company, today announced it has received European CE MDR Class IIa medical device certification for its optical fingertip blood pressure monitoring app, OptiBP™ — the first and only software app worldwide to receive the CE mark for measuring blood pressure on a smartphone. The achievement marks a major milestone for Biospectal as it affirms the app’s compliance with stringent European Union CE MDR regulations for medical device certification and furthers Biospectal’s mission to democratize access to blood pressure monitoring worldwide. Biospectal now has access to more than 30 countries worldwide. Biospectal OptiBP for Android will be available first in Switzerland, Germany, Austria and France via Google Play starting in early 2024. View a short video of Biospectal in action here.
“OptiBP is a game changer from a clinician’s perspective. It eliminates the difficulty of measuring blood pressure and offers a real solution to getting patients to monitor frequently enough for proper clinical follow-up. Fingertip measurement is a vastly better option than the blood pressure cuff,” said Dr. Patrick Schoettker, Biospectal Chief Medical Advisor and Professor and Head of the Department of Anesthesiology at Lausanne University Hospital (CHUV) in Lausanne, Switzerland.
Dubbed the “silent killer,” a recent World Health Organization report estimates that 1.3 billion people worldwide have untreated or uncontrolled hypertension (blood pressure of 140/90 mmHg or higher). Hypertension affects one in three adults worldwide, and nearly half of those affected are currently unaware of their condition. Further, approximately four out of every five people with hypertension are not adequately treated, and more than three-quarters of adults with hypertension live in low- and middle-income countries.
How Biospectal OptiBP works.
The Biospectal OptiBP app uses the built-in camera lens on a smartphone to record an individual’s blood flow easily via their fingertip.Biospectal’s proprietary algorithms and optical signal analysis methods then transform the captured data into blood pressure values. OptiBP records fingertip blood flow optically and transforms that information into a pulse wave that it analyzes to estimate blood pressure. A measurement is rendered in 30 seconds — much quicker than a blood pressure cuff. By allowing blood pressure to be measured at the ‘point of patient,’ OptiBP enables more frequent, trackable and shareable information to support better blood pressure management and better life outcomes.
“Our mission is to bring clinical capabilities to patients’ hands to empower them to keep track and manage their heart health,” said Eliott Jones, CEO and co-founder of Biospectal. “Increasingly, effective and more frequent blood pressure measuring and tracking is an important factor in helping people to partner with their doctors to manage hypertension. Biospectal’s patented OptiBP technology replaces the cumbersome, antiquated traditional blood pressure cuff and removes the barriers to frequent blood pressure monitoring by making the process easy with the touch of the fingertip to your smartphone’s camera. We envision a future where individuals can easily measure their blood pressure anytime, anywhere. That’s a real breakthrough.”
Clinically Validated Technology.
Developed in partnership with the prestigious Swiss Center for Electronics and Microtechnology, Biospectal’s software algorithms represent over 15 years of optical biosensing research and development.
The OptiBP CE Mark opens up new opportunities for Biospectal to collaborate with healthcare organizations, insurers and other strategic partners globally to integrate the OptiBP app into existing digital health platforms and to develop innovative telemedicine solutions.
