Informed Vital Core Application (IVC App)

The Mindset Medical, Inc. IVC App is a software-based medical device designed for non-invasive, spot pulse rate measurement using common smart device cameras. It employs remote plethysmography (rPPG) by detecting subtle facial color variations and has demonstrated accuracy and comparability through extensive testing and clinical studies.

Mindset Medical, Inc. has developed the Informed Vital Core Application (IVC App), a software-based product designed for the non-invasive spot measurement of pulse rate. Following a thorough evaluation, this device has been determined to be comparable to other similar medical products already available, allowing it to be introduced for widespread use. The IVC App is intended for adult patients aged 22 years or older in settings such as homes, hospitals, clinics, and long-term care facilities. It is not designed for critical care, continuous vital signs monitoring, or to independently direct therapy. Operating as a Software as a Medical Device (SaMD), the IVC App utilizes existing optical camera technology in common smart devices like phones, tablets, and computers. It employs remote plethysmography (rPPG) to estimate pulse rate by detecting subtle color variations in the patient's face. Extensive testing, including software verification, validation, hardware compatibility, human factors, and cybersecurity assessments, confirmed its performance. Clinical studies also demonstrated the device's accuracy in pulse rate measurements.

AI Regulatory Concerns

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• Q1. What are the specific accuracy metrics (e.g., mean absolute error, standard deviation) demonstrated in the clinical studies for the IVC App's pulse rate measurements?; How does the IVC App's performance compare to traditional pulse oximetry or ECG-based pulse rate monitoring in diverse patient populations or skin tones?; What are the limitations or specific environmental conditions that might affect the IVC App's rPPG accuracy (e.g., lighting, patient movement, facial hair)?; Given its SaMD classification, what cybersecurity measures are in place to protect patient data and prevent unauthorized access or manipulation of the device's functionality?; What are the long-term plans for IVC App integration with electronic health records (EHRs) or telehealth platforms, and what regulatory considerations apply to such integrations?