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Australia Clears Apple Watch Hypertension Alerts as Medical Device

The regulatory listing covers a pattern‑detection feature that flags possible high blood pressure from month‑long optical heart‑sensor trends.

Overview

  • Australia’s Therapeutic Goods Administration approved and listed the software on the Australian Register of Therapeutic Goods, allowing legal activation once Apple sets a launch date.
  • The system analyzes photoplethysmography data over rolling 30‑day periods to detect signals linked to chronic hypertension, then advises confirmation with a cuff and clinical follow‑up.
  • Eligibility applies to adults 22 or older who are not pregnant and have no prior hypertension diagnosis, with support limited to Apple Watch Series 9 or later or Apple Watch Ultra 2 or later on watchOS 26 paired with an iPhone 11 or newer.
  • Hypertension notifications are already available in more than 150 countries, and Australia’s clearance aligns the country with those markets.
  • Apple cites independent validation involving thousands of participants, and the company and medical experts estimate the feature could help notify over one million people who may be undiagnosed.