The team behind the OptiBP app that uses a smartphone’s camera to accurately record blood pressure has announced the publication of clinical study results that validate the accuracy of the technology.
Conducted by the team of Prof. Patrick Schoettker at CHUV Lausanne University hospital and the University of Lausanne UNIL in Switzerland, the study results confirm Biospectal OptiBP meets the ISO 81060-2 international protocol for accuracy for blood pressure measurement devices. The study results also reinforce the clinical accuracy of Biospectal’s OptiBP software-based smartphone app solution to accurately measure blood pressure utilizing transdermal optical sensing with only a fingertip applied to the lens of a smartphone camera.
“While cuffless blood pressure measurement devices such as dedicated wrist bands and smartwatches exist in the market, Biospectal is the only validated, software-based smartphone app solution that meets the ISO 81060-2 international protocol for accuracy,” said Biospectal CEO and co-founder Eliott Jones. “Biospectal OptiBP makes a huge leap in the ease of blood pressure monitoring and management by enabling convenient, frequent monitoring capability via a smartphone app. As a result, Biospectal OptiBP is well-positioned to become the new essential tool, not only for daily blood pressure monitoring but also for communication with physicians in times of growing telehealth practices.”
The Blood Pressure Monitoring Journal study demonstrates the accuracy of the Biospectal OptiBP smartphone app to estimate the blood pressure of participants using a standardized protocol set by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). The study complies with the ISO 81060-2 norm, which establishes a list of standardized criteria to validate the accuracy of a new non-invasive blood pressure measurement device.
A comparison was performed between a standard measure (auscultatory blood pressure estimation with a double stethoscope and independent blinded experienced observers) and the cuffless Biospectal OptiBP device to obtain the results. Results demonstrate a mean error of 0.5 ± 7.7 mmHg for systolic and 0.4 ± 4.6 mmHg for diastolic blood pressure, within the ISO 81060-2 norm’s allowable ±5 mmHg mean error and standard deviation of ±8 mmHg for systolic and diastolic blood values. As a result, Biospectal OptiBP’s performance meets the ISO 81060-2 requirement and demonstrates equivalent performance to the standard inflatable cuff.
According to the World Health Organization, high blood pressure or hypertension is the number one chronic condition and a major cause of premature death worldwide and the most important, modifiable risk factor for cardiovascular disease. Dubbed “the silent killer,” hypertension has no noticeable symptoms to indicate something is wrong. Undiagnosed and uncontrolled hypertension are two of the most significant contributing factors to morbidity and mortality. The best ways for patients to protect themselves are being aware of the risks of hypertension and making positive lifestyle changes.
“The study by the Blood Pressure Monitoring Journal further validates the precision of software-as-a-medical-device technology in a standardized clinical setting, and marks an important milestone to democratize access to blood pressure measurement for hypertensive patients worldwide,” said Prof. Patrick Schoettker, M.D., Chief Medical Advisor at Biospectal. “Access to smartphone-based solutions to measure blood pressure will allow widespread diagnosis of hypertension and could thereby improve management of hypertensive patients in various settings. This is particularly true in low-income countries where blood pressure devices are scarce, but smartphone penetration is high.”
Backed by grants from the Bill & Melinda Gates Foundation and Global Grand Challenges Canada’s Saving Lives at Birth initiative, Biospectal also recently launched two global, independent research and validation studies using Biospectal OptiBP. Currently underway in four low-resource countries, the studies center on the routine measurement and monitoring of blood pressure, assessment of hypertension during pregnancy, and enable global field testing and validation of Biospectal’s OptiBP smartphone app and data platform integration with the WHO’s Digital Antenatal Care module, following WHO SMART guidelines and built on the WHO Open Smart Register Platform (OpenSRP). Biospectal’s patented OptiBP technology was co-developed and clinically validated by the Swiss Center for Electronics and Microtechnology (CSEM). A large-scale, third-party research study published in Scientific Reports in Nature in October 2020 also demonstrated Biospectal’s ability to measure blood pressure as accurately as a sphygmomanometer, commonly referred to as a standard blood pressure cuff.