Overview

FaceHeart, a Taiwanese technology firm, has secured regulatory approval from the United States for its innovative AI-powered, contactless method of measuring respiratory rates. The company received a 510(k) clearance from the US Food and Drug Administration (FDA) for the respiratory rate measurement feature of its software development kit (SDK).

Details of the Technology

• FaceHeart’s SDK utilizes a smartphone camera to capture vital signs, including:
  • Heart rate
  • Respiratory rate
  • Blood pressure
  • Oxygen saturation
  • Heart rate variability
• The measurement process takes less than 50 seconds and employs advanced technologies such as:
  • Computer vision
  • Remote photoplethysmography (rPPG)
  • Deep learning
• According to the FDA’s evaluation, the respiratory rate component showed consistent deviations within ±2 breaths per minute across various devices.

Previous Approvals

This recent FDA approval marks FaceHeart’s second clearance, following the 510(k) approval for the heart rate measurement component of its SDK earlier in 2023.

Integration and Applications

The FaceHeart SDK can be integrated into a variety of edge devices, including smartphones, tablets, and computers. It performs analysis using edge computing, which enhances security and reduces network latency. The technology is applicable in several areas, including:

• Preventive health
• Telemedicine
• Elderly care
• Chronic disease management

Market Context

In recent years, numerous smartphone applications utilizing photoplethysmography (PPG) signals to monitor vital signs have emerged. Notable examples include:

• Google Fit
• MFine from India
• Advanced Health Intelligence from Australia

Additionally, the National Taiwan University Hospital and its partner, FocalTech Smart Sensors Co., have developed a mobile app that measures heart rhythm using a smartphone camera to scan a user’s fingertip.

In Canada, NuraLogix has launched the Anura app for vital signs measurement in Singapore. Other innovations include smartphone camera technologies for stroke detection and prediction, developed by institutions such as Penn State University and Houston Methodist Hospital in the US, as well as RMIT University in Australia.