Biozen Receives FDA Clearance for Calibration-Free Cuffless Blood Pressure Technology

Handheld fingertip device delivers clinical-grade readings — no cuff, no calibration, no compromise. 

OKLAHOMA CITY, May 11, 2026 /PRNewswire/ -- Biozen today announced FDA 510(k) clearance for the BP1000, the first cuffless blood pressure device cleared in the United States to deliver calibration-free, clinically validated spot measurement from the fingertip.

Cuffless blood pressure has been one of the most pursued goals in health technology, with major device makers and startups working on the problem for more than a decade. The BP1000 is the result of years of engineering, clinical research, and validation work to make that goal real.

"We've spent years proving that accurate blood pressure measurement doesn't require a cuff," said Dikran Tourian, Chief Executive Officer of Biozen. "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."

How It Works

The BP1000 uses the same proven science as an automated cuff to measure absolute blood pressure — applied through the fingertip rather than an inflatable arm cuff. The user gently presses down on the device's sensors while following a visual target in the companion app, gradually applying the pressure needed to achieve arterial occlusion. The device pairs proprietary pressure sensing with photoplethysmography (PPG) — an optical technique that detects changes in blood volume — to precisely identify when occlusion occurs, then computes blood pressure through physiologically informed algorithms. The app logs every reading and presents a complete measurement history.

Because the device measures the underlying physiology directly rather than estimating it from indirect signals, it requires no per-user calibration against a cuff — an essential requirement that has limited earlier cuffless approaches.

The technology was validated against ISO 81060-2:2018, the international standard for non-invasive blood pressure devices, demonstrating equivalence to traditional cuff-based reference measurements.

"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," said Omer Inan, PhD, Chief Scientific Officer of Biozen and Professor of Electrical and Computer Engineering at the Georgia Institute of Technology. "FDA clearance reflects what the data shows — that, when done properly, this approach doesn't require a cuff to be accurate."

"I've watched cuffless blood pressure get announced for years, and most of it hasn't met the bar clinicians need," said Kenneth Civello, MD, cardiologist and electrophysiologist, and advisor to Biozen. "What's different about the BP1000 is that it's measuring blood pressure, not estimating it. That distinction matters — and it's why FDA clearance is the right milestone for this technology."

Rollout

Biozen is taking a phased approach to U.S. market introduction, advancing toward broad commercial launch in late 2026. An early access program is open now for clinicians, partners, and individuals interested in being among the first to use the technology.

The company is focused on scaling manufacturing, expanding clinical and commercial partnerships, and supporting integration of its sensing platform into future devices.

"The biggest gap in hypertension care isn't necessarily measurement accuracy — it's how often people actually measure," Tourian added. "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."

Interested partners, clinicians, and users can learn more and request early access at biozen.com.

About Biozen

Redefining how the world measures blood pressure.

Biozen is a privately held digital health company headquartered in Oklahoma City, Oklahoma, with research and development in Atlanta, Georgia. The company's cuffless blood pressure platform — protected by more than 68 granted U.S. and international patents — integrates advanced biosensors with proprietary algorithms to deliver calibration-free, clinical-grade blood pressure readings at the fingertip.

About the BP1000

The Biozen BP1000 Ultra-Compact Fingertip Blood Pressure Monitor is a digital monitor intended for use in spot check measurements of blood pressure in the adult population using photoplethysmogram and pressure signals obtained from the index finger.

User Population: Adults ages 22-59 who do not have active arrhythmias (e.g. Afib), peripheral artery disease, or are pregnant.

Environment of Use: Home

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SOURCE Biozen, LLC