TechConnect Innovation Program

I-PASS: Intracranial Pressure Assessment and Screening System

CranioSense, MA, United States

TECHNOLOGY SUMMARY

I-PASS utilizes three small external sensors to calculate intracranial pressure (ICP). ICP is an important marker of brain health, but there is no current system for monitoring it noninvasively. I-PASS uses near-infrared sensors on the forehead, ear, and finger for blood flow information, from which ICP is calculated.

Primary Application Area: Medical Devices

Technology Development Status: Prototype

Technology Readiness Level: TRL 6

FIGURES OF MERIT

Value Proposition: I-PASS is a highly promising technology by which we can record an important brain parameter quickly and safely. I-PASS can be used in a hospital setting, to replace invasive methods and their associated risks, but also brings monitoring of this important vital sign further forward in the injury cascade.

SHOWCASE SUMMARY

Organization Type: Early-stage Startup (Seed)

National Innovation Awardee

Showcase Booth #: 33M

Website: www.craniosense.com

GOVT/EXTERNAL FUNDING SOURCES

Government Funding/Support to Date: Contract/IR&D Purpose
W81XWH-07-C-0011 ICP detection method identified from several tested
W81XWH-09-C-0118 Initial validation in animal model
N68335-10-C-0079 System robustness established in operationally relevant environment; initial pilot study in healthy humans
W81XWH-13-C-0187 Final animal study; ICU human data; initial FDA approval for 510(k) clearance based on ICU indication

Primary Sources of Funding: Federal Grant

Looking for: Both Funding and Development Partners