FDA Moves to Ease Cuffless Blood Pressure Device Rules as Vital Signals Seeks Clearance

FDA Moves to Ease Cuffless Blood Pressure Device Rules as Vital Signals Seeks Clearance

In January 2026 the FDA began crafting broader regulatory exemptions for cuffless, non-invasive blood pressure devices using optical heart rate monitors. Vital Signals, founded by ex-Android engineer Tom Moss, is pursuing FDA clearance for its $399 Signal Ring in that category, with the long-term goal of insurer partnerships for preventative care.

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