Swiss biosensing software company Biospectal has secured the European CE MDR Class IIa medical device certification for OptiBP, an optical fingertip blood pressure monitoring software app.
OptiBP is now said to be the first and only software app in the world to get a CE mark for the measurement of blood pressure on a smartphone.
It uses the built-in camera lens on a smartphone to capture an individual’s blood flow easily through their fingertip. This data is converted by Biospectal’s proprietary algorithms and optical signal analysis techniques into blood pressure values.
The OptiBP app uses an optical recording of the fingertip blood flow to create a pulse wave, which is then assessed to determine blood pressure.
According to the biosensing software firm, the measurement takes only 30 seconds, which is significantly faster than a blood pressure cuff.
OptiBP also enables blood pressure to be recorded at the point of patient to facilitate more frequent, trackable, and shareable information to assist in improved blood pressure management and better life outcomes.
Biospectal CEO and co-founder Eliott Jones said: “Our mission is to bring clinical capabilities to patients’ hands to empower them to keep track and manage their heart health.
“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.”
The optical fingertip blood pressure monitoring software app showed accuracy across different settings in a study, whose results were published in May 2023. It was developed in collaboration with the Swiss Center for Electronics and Microtechnology.
The CE Mark will allow Biospectal to work with insurers, and healthcare organisations globally to connect the OptiBP app with already-existing digital health platforms.
Biospectal OptiBP for Android is set to debut on Google Play in Switzerland, Germany, Austria, and France in early 2024.