Medical devices, digital health and remote monitoring — viva

Opening (must-hit)

"A paediatric medical device is any regulated instrument or software used to diagnose, monitor or treat a child. The four classes are implantable or long-term, wearable or on-body, home monitoring and telehealth platforms, and the candidate must distinguish a regulated medical-grade device from a consumer wellness product. The two highest-yield sensor physiologies are the continuous glucose monitor — interstitial glucose lagging plasma by five to fifteen minutes — and the pulse oximeter, which is biased by dark skin pigmentation and low perfusion. The ISPAD 2024 ambulatory glucose profile targets are time in range over 70 per cent, time below 70 mg/dL under 4 per cent, time below 54 mg/dL under 1 per cent. Every device is deployed only after the clinical question, the age validation, the thresholds and the escalation pathway are agreed with the family." ^{[4] [8]}