The app uses an iPhone or iPad camera to measure pulse rate in 30 seconds.


Summary:

PanopticAI has received FDA 510(k) clearance for its vital signs app, a mobile application that uses an iPhone or iPad camera to measure pulse rate without physical contact. The app leverages remote photoplethysmography algorithms to detect subtle skin color changes, providing pulse rate measurements within 30 seconds. Clinical testing was conducted on a diverse patient population to validate accuracy, and the app underwent cybersecurity and human factors testing to ensure reliability and ease of use, according to the company. Already adopted by hospitals, insurers, and pharmacies, the technology aims to improve access to vital sign monitoring.

Key Takeaways:

  1. PanopticAI’s Mobile App Receives FDA Clearance – The vital signs app, which measures pulse rate using a smartphone or tablet camera, has been cleared for medical use.
  2. Clinical Testing Ensured Accuracy Across Diverse Populations – The app was validated through testing on a broad patient group and under various conditions, including different lighting and distances.
  3. Technology Expands Access to Contactless Vital Sign Monitoring – By eliminating the need for specialized equipment, the app aims to provide a cost-effective solution already in use by hospitals, insurers, and pharmacies.

Hong Kong-based health technology company PanopticAI has received 510(k) clearance from the US Food and Drug Administration (FDA) for its contactless vital signs monitoring mobile application. 

The PanopticAI Vital Signs app is the first FDA-cleared mobile application for contactless pulse rate measurement using the built-in camera of iPhones and iPads, according to the company. It leverages proprietary remote photoplethysmography algorithms to transform readily available smartphones and tablets into medical-grade vital sign monitors. 

Advanced AI and signal processing techniques are used to analyze subtle color changes in the skin captured by the device’s camera, measuring vital signs like pulse rate in 30 seconds.

By leveraging the ubiquity of smartphones, PanopticAI’s technology eliminates the need for specialized equipment, reducing costs and expanding access to vital sign monitoring for a wider population. The company’s contactless vital signs monitoring technology is already used by hospitals, insurance providers, and pharmacies. Its customers include Gleneagles Hospital Hong Kong (part of IHH Healthcare), Mannings (a Hong Kong health and beauty chain), and Bupa (a multinational health insurer).

Testing Validates Accuracy, Security, and Usability

Clinical testing was conducted on a diverse patient population reflecting US census data to ensure the accuracy and reliability of the PanopticAI Vital Signs app across a broad range of users, according to the company. Rigorous non-clinical testing evaluated the app’s performance under various conditions, including different lighting, distances, and user characteristics, to ensure reliable operation in real-world settings. 

The PanopticAI Vital Signs app also underwent cybersecurity and human factors testing to ensure patient safety and ease of use.

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“We are delighted to receive FDA clearance for our technology, validating our commitment to developing clinically sound, accessible health solutions,” says Kyle Wong, CEO and co-founder of PanopticAI, in a release. “This clearance for contactless pulse rate measurement is the first of several anticipated approvals, and we look forward to building upon this success as we expand our technology’s capabilities.”

Kenneth Tsang, chief executive officer of Gleneagles Hospital Hong Kong and regional chief executive officer of IHH Healthcare North Asia, says in a release, “Gleneagles embraces innovative solutions and new technologies to make personalized healthcare more accessible and encourage patients to have better awareness and management of their own health and wellbeing. As the first private hospital in Hong Kong to collaborate with PanopticAI to adopt the solution in the hospital’s mobile application, we are pleased to be able to help more patients through participating in the validation of the reliability and effectiveness of this innovative technology.”

The PanopticAI Vital Signs app is not intended to be the sole method to assess a subject’s physical health condition. The measurements it provides should complement, not replace, professional medical care and/or medication.

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