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.”

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