Tag: FDA Cleared

  • Apple Watch Blood Pressure Feature Receives FDA Approval

    Apple Watch Blood Pressure Feature Receives FDA Approval

    Key Takeaways

    1. Nearly half of the US population is affected by hypertension, increasing the risk of serious cardiovascular issues.
    2. Apple’s new Hypertension Notifications feature can identify early signs of hypertension and is set to receive FDA clearance on September 15, 2025.
    3. The feature will be available in about 150 countries and will debut on the Watch Ultra 3 and Series 11, starting at $399.
    4. The Notifications utilize advanced machine learning, analyzing data from over 100,000 participants and tested in a clinical trial with about 2,000 participants.
    5. Apple recommends confirming alerts with a 7-day blood pressure monitoring conducted by a healthcare professional.


    Elevated blood pressure, commonly known as hypertension, is estimated to impact nearly half of the population in the US. Recent studies indicate that receiving a prompt diagnosis can greatly decrease the chances of experiencing serious cardiovascular issues, such as strokes or heart attacks.

    Apple’s New Feature

    Apple has rolled out a feature that can identify early signs of hypertension with its latest flagship Watches, even though it lacked initial regulatory approvals.

    Now, the Hypertension Notifications feature is set to receive official clearance from the FDA, with its launch scheduled for next week, beginning September 15, 2025.

    Global Availability

    The Notifications are expected to be accessible in approximately 150 countries around the globe over time. They have made their debut in the new Watch Ultra 3 and Series 11, which starts at $399 on Amazon. Apple also mentioned that the feature will later be available on the Series 9 and 10 and the Ultra 2 once they update to watchOS 26.

    Apple claims that these Notifications were created using advanced machine learning that analyzed data from more than 100,000 participants across various studies, and were tested in a clinical trial involving around 2,000 participants.

    Important Recommendations

    Despite this innovation, the company advises that any alerts should be confirmed with the results from a 7-day blood pressure monitoring conducted using specialized medical equipment, evaluated by a healthcare professional, to actually diagnose hypertension.

    Source:
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  • Withings BPM Pro 2: FDA-Approved Award-Winning Blood Pressure Monitor

    Withings BPM Pro 2: FDA-Approved Award-Winning Blood Pressure Monitor

    The Withings BPM Pro 2, a blood pressure monitor that uses cellular technology, has received FDA clearance. Withings states that this device is the first of its kind, enabling remote monitoring for healthcare providers.

    Launch and Features

    The BPM Pro 2 was introduced in October when the company announced it was pursuing FDA clearance prior to the device’s launch. It’s important to mention that Withings is still waiting for FDA approval for its 1-lead ECG, which will help detect atrial fibrillation, and is expected to be available in 2025. The BPM Pro 2 allows patients to check their diastolic and systolic blood pressure along with their pulse rate from the comfort of their homes. Additionally, there are Patient Insights questionnaires to provide context to the data, and the device can prompt users to retake measurements when necessary.

    Availability and Pricing

    Healthcare professionals can now purchase the Withings BPM Pro 2, although the exact price has not been disclosed. In other updates, Withings has announced that the BPM Pro 2 has been recognized as a CES 2025 Innovation Awards Honoree in the Digital Health category. For those in need of a consumer-grade blood pressure monitor, Withings has the BPM Connect available, which is currently priced at $90.32 on Amazon.

    Recognition and Other Products

    Withings continues to expand its range of smart health devices, focusing on user-friendly technology for better health management. The BPM Pro 2 stands out among its offerings, demonstrating the company’s commitment to innovation in health monitoring.

    Source: Link