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AuraLife settles matter with the U.S. Federal Trade Commission

Court documents show that the Commission, in its complaint, does not dispute that AuraLife’s current, smartphone-based blood pressure product provides estimates of blood pressure to the performance characteristics published by the company; Commission agrees to settle with AuraLife and its CEO with no admission of fault or wrong-doing and with no monetary payment. AuraLife views the settlement and the understanding that was established during its discussions with FTC staff as a win for the company.

The Blood Pressure app estimates blood pressure with your smartphone and our algorithm

Do not rely on Blood Pressure for medical advice or diagnosis. It is not as accurate as and is not a substitute for a cuff or other blood pressure monitor. It is not suitable for use by individuals whose blood pressure falls outside of our supported Systolic range of 83 - 178 (mmHg) or our supported Diastolic range of 58-107 (mmHg).

 

Learn the science & performance characteristics

HOW It WORKS

Produce an Blood Pressure estimate in under 35 seconds:

Remove any phone case and place right index finger over the rear camera lens and flash.


Remove any phone case and place right index finger over the rear camera lens and flash.

Maintaining finger over the camera and flash, place the bottom of the phone in direct chest contact using firm and steady pressure. 


Maintaining finger over the camera and flash, place the bottom of the phone in direct chest contact using firm and steady pressure. 

Hold position still and quiet until the session is complete. See estimate.


Hold position still and quiet until the session is complete. See estimate.

Use Blood Pressure to estimate blood pressure and pulse rate immediately before, during, or after a recreational activity.

Do not rely on Blood Pressure for medical advice or diagnosis. 

Do not use Blood Pressure as a replacement or substitute for a cuff or other blood pressure monitor. It is not as accurate as a cuff or other monitor. 

Blood Pressure is not suitable for use by individuals whose Systolic or Diastolic blood pressure is outside our supported range of 83-178 (mmHg) or 58-107 (mmHg), respectively. 

Consult your doctor if you have any health concern. Do not self-­adjust medications.

Do not use Blood Pressure if you wear a pacemaker or any internal electronic medical device. 

THE SCIENCE

Through years of physiological data collection, research, and development we have built a digital bio-marker processing platform which leverages pulse activity, mechanical cardiac activity, and proprietary vascular indices. All of this bio-data can be collected using the everyday sensor suite present in a modern smartphone device. Many of these features represent new discoveries on our team's part while others represent features that have been well documented in peer-reviewed clinical research. Blood Pressure's algorithm leverages our unique discoveries, well understood biometrics, and each user's unique anthropometric data to produce each blood pressure estimate. No smartphone hardware accessory required!

The Company behind Blood Pressure

AuraLife’s mission has been to help people better access health insight. The company has envisioned a future where mobile technology plays a central role in helping people pursue their health and wellness goals. Blood Pressure is a novel system that has leveraged recent advances across industry and academia in mobile sensor technology, machine learning techniques, and physiological understanding. AuraLife has been proud to have built a technology which has aimed to help people live happier and healthier lives.

System Performance Details

Updated: April 19th, 2016 11:30 AM PT
IBP Algorithm v3 Production Launch Date: April 8th, 2016

For reference, we conduct internal studies guided by the ANSI/AAMI/ISO 81060-2:2013 internationally-accepted protocol for blood pressure cuff performance assessment to develop the performance characteristics of the technology powering Blood Pressure. The performance characteristics of Blood Pressure and other important safety and intended use information are included below.

Details & Results

These performance characteristics are developed through an in-house study using the ANSI/AAMI/ISO 81060-2:2013 protocol modified to compare Blood Pressure to reference upper-arm, oscillometric blood pressure cuff devices. The results of this study find that Instant Blood Pressure does not yet meet the performance standards set forth by the ANSI/AAMI/ISO 81060-2:2013 protocol and, for this reason, it provides an estimate of blood pressure only. Furthermore, traditional automated upper-arm blood pressure monitors are currently more accurate and provide blood pressure readings over a greater range than Blood Pressure.

Systolic BP Supported Range†:

  • 83 - 178 (mmHg)
  • Total Range: 95 (mmHg)

Systolic BP Accuracy*:

  • Mean: +2.7 (mmHg)
  • SD (Sm): 12.8 (mmHg)
  • SD (Sn): 13.9 (mmHg)
  • RMSD: 14.1 (mmHg)
  • Pearson: r=0.755 (P<0.0001)

Systolic Data:

  • Number of Determination Pairs: 266
  • Subjects:
    • Number (n): 99
    • Number Males: 65
    • Age (years): 37 ± 15 (Min: 18, Max: 79)
    • Weight (lbs): 180.7 ± 44.8 (Min: 116.0, Max: 305.0)
    • Height (in): 66.9 ± 3.6 (Min: 59.0, Max: 75.0)

Diastolic BP Supported Range†:

  • 58-107 (mmHg)
  • Total Range: 49 (mmHg)

Diastolic BP Accuracy*:

  • Mean: +2.6 (mmHg)
  • SD (Sm): 8.4 (mmHg)
  • SD (Sn): 8.8 (mmHg)
  • RMSD: 9.2 (mmHg)
  • Pearson r=0.744 (P<0.0001)

Diastolic Data:

  • Number of Determination Pairs: 258
  • Subjects:
    • Number (n): 97
    • Number Males: 63
    • Age (years): 37 ± 15 (Min: 18, Max: 79)
    • Weight (lbs): 180.6 ± 45.3 (Min: 116.0, Max: 305.0)
    • Height (in): 66.9 ± 3.7 (Min: 59.0, Max: 75.0)

Pulse Rate Range†:

  • 39-240 (bpm)
  • Total Range: 201 (bpm)

Pulse Rate Accuracy*:

  • Mean: +0.9 (bpm)
  • SD (Sm): 3.0 (bpm)
  • SD (Sn): 3.6 (bpm)
  • RMSD: 3.7 (bpm)
  • Pearson r=0.955 (P<0.0001)

Pulse Rate Data:

  • Number of Determination Pairs: 268
  • Subjects:
    • Number: 99
    • Number Males: 65
    • Age (years): 37 ± 15 (Min: 18, Max: 79)
    • Weight (lbs): 180.7 ± 44.8 (Min: 116.0, Max: 305.0)
    • Height (in): 66.9 ± 3.6 (Min: 59.0, Max: 75.0)

 

† Blood Pressure will not produce an estimate outside of its supported range. Do not attempt to use Blood Pressure to produce a reading outside of its range. If you know your blood pressure or pulse rate to fall outside this range or if you intend to estimate blood pressure or pulse rate outside of this range, Blood Pressure is not suitable for your use.

* Mean = mean difference compared to reference, SD = standard deviation of difference. RMSD = root mean squared deviation. Pearson = Pearson correlation coefficient with reference. This accuracy characteristic is representative of the supported range only. Accuracy performance may be poor outside of the supported range.