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

Biozen has received FDA 510(k) clearance for BP1000, a cuffless blood pressure device designed to provide calibration-free spot measurements from the fingertip.

The clearance is a significant regulatory milestone for cuffless blood pressure monitoring, an area that has attracted sustained interest from health technology companies seeking to make routine blood pressure measurement more accessible and less burdensome for patients.

Hypertension remains one of the most widespread cardiovascular risk factors. Biozen noted that nearly half of US adults have hypertension, yet blood pressure measurement for many people still takes place only occasionally. This creates a monitoring gap, particularly for patients who may not measure regularly because traditional cuffs are bulky, uncomfortable or inconvenient.

BP1000 is designed as a handheld fingertip device rather than a wearable or conventional upper-arm cuff. Users gently press down on the device’s sensors while following a visual target in a companion app, gradually applying the pressure needed to achieve arterial occlusion.

The device combines proprietary pressure sensing with photoplethysmography, an optical technique used to detect changes in blood volume. Biozen said this allows BP1000 to identify when occlusion occurs and calculate blood pressure using physiologically informed algorithms. The companion app logs each reading and provides a measurement history.

A key feature of the technology is that it does not require per-user calibration against a cuff. Earlier cuffless approaches have often depended on indirect signal estimation or calibration steps, which can limit practical adoption in routine care. Biozen positions BP1000 as measuring the underlying physiology directly rather than relying only on correlation-based estimation.

The technology was validated against ISO 81060-2:2018, the international standard for non-invasive blood pressure devices, and demonstrated equivalence to traditional cuff-based reference measurements. This validation is important for clinician confidence, particularly as cuffless monitoring technologies move from consumer wellness use cases toward regulated medical applications.

The company plans a phased US market introduction, with a broader commercial launch expected later in 2026. Biozen has also opened an early access programme for clinicians, partners and individuals interested in using the technology.