Vittamed has developed a non-invasive ICP meter using safe ultrasound technology by measuring ICP using blood flow parameters in two pieces of ophthalmic artery: intracranial and extracranial. The non-invasive ICP meter is clinically validated against invasive methods of ICP in adult population (older than 18 years) but is not validated in children. The goal is to adopt this technology for pediatric patients (older than 8 years) by redesigning head frame used for ultrasonic measurement to fit comfortably around a child’s head; and redesign the head frame so that ultrasound transducers could insolate simultaneously two segments of ophthalmic artery (intracranial and extracranial) for children. NCC-PDI has provided $50,000 in direct funding.
Year:
2014
Anticipated Classification:
Class II
Anticipated Regulatory Path:
510(k)
Initial Development Stage:
Clinical
Current Development Stage:
Clinical
