Oklahoma City–based Biozen says it marks the first cuffless blood pressure device cleared in the U.S. for calibration-free, clinically validated spot measurement from the fingertip. It joins a handful of other FDA-cleared cuffless blood pressure devices, including those from Biobeat and Aktiia.
BP1000 uses the same proven science as an automated cuff, but applies it through the fingertip to measure blood pressure. The user gently presses down on the device’s sensors while following a visual target in a companion app. They gradually apply the pressure required to achieve arterial occlusion.
Biozen’s device pairs proprietary pressure sensing with photoplethysmography (PPG). This optical technique detects changes in blood volume to precisely identify when occlusion occurs. It then computes blood pressure through physiologically informed algorithms. The app logs every reading and presents a complete measurement history.
According to the company, its device requires no per-user calibration against a cuff because it measures underlying physiology directly, rather than estimating from indirect signals. Biozen said this requirement often limited earlier cuffless approaches.
With FDA clearance, the company plans a phased approach to U.S. market introduction. It expects to begin a broader commercial launch late this year. The company already has an early access program open for clinicians, partners and individuals interested in using the technology.
Commentary from Biozen officials
Dikran Tourian, CEO of Biozen, said:
“We’ve spent years proving that accurate blood pressure measurement doesn’t require a cuff. Nearly half of U.S. adults have hypertension, yet for most people, measurement still happens only occasionally. FDA clearance allows us to begin making routine, clinically validated spot blood pressure measurement far more accessible.
“The biggest gap in hypertension care isn’t necessarily measurement accuracy — it’s how often people actually measure. Millions of people avoid regular monitoring because cuffs are bulky, inconvenient, and uncomfortable. A device this small, this simple, and this portable changes the compliance equation — patients can take their blood pressure anywhere, which means they’ll take it more often.”
Omer Inan, chief scientific officer of Biozen and professor of electrical and computer engineering at the Georgia Institute of Technology, said:
“The BP1000 isn’t built on black box estimation or correlation — it’s built on the same direct measurement principles that have defined accurate blood pressure for decades. FDA clearance reflects what the data shows — that, when done properly, this approach doesn’t require a cuff to be accurate.”
