CranioSense
Techstars '24Bedford, US · Founded 2022 · 6 employees on LinkedIn · 2 known investors
CranioSense develops IPASS, a non-invasive medical device that measures intracranial pressure using a forehead patch and handheld device, eliminating the need for invasive skull drilling in traumatic brain injury assessment.
Also known as CranioSense, Inc.
Founders & leadership
CranioSense was founded in 2022 by Gordon Hirschman, Ryan Myers, and Kristian DiMatteo.
Investors · 2
Company profile
researched Aug 2026CranioSense is a clinical-stage medical device company based in Bedford, Massachusetts, developing a portable system for non-invasive assessment of intracranial pressure (ICP). The company's system, referred to on its site as IPASS (Intracranial Pressure and Assessment Screening System) and IHdetect, consists of a forehead patch, two clip-on sensors and a handheld device roughly the size of a tablet, and is intended to produce an ICP assessment in seconds.
The company frames its target problem around traumatic brain injury (TBI): elevated cranial pressure can cause brain damage, seizure, coma, stroke or death, but the standard measurement method requires drilling a hole in the skull and inserting a sensor into the brain. Because that procedure is invasive and carries added risk, it is generally reserved for critically ill patients, and by the company's account only about 2% of people with TBI have their cranial pressure tested. CranioSense positions its system as a way for clinicians to triage and monitor elevated ICP earlier in the care journey, including in pre-hospital and emergency-department settings.
Business model
Medical device developer; the company states it is a clinical stage company seeking private investment. Its technology is licensed from Vivonics, Inc., whose CEO is a CranioSense co-founder and board chair.
Traction
CranioSense reports having worked with 13 clinical sites and interviewed more than 150 physicians across the United States. Completed studies include a healthy-human correlation study and a direct comparison against the ICU gold standard across seven US ICU sites, where the algorithm showed 91% sensitivity and 95% specificity for diagnosing intracranial hypertension on training data. An ongoing pilot validation of the diagnostic algorithm is being conducted with neuroradiology at Massachusetts General Hospital against lumbar puncture opening pressure, with n=30 and anticipated completion in August 2025. The company was named top winner of the 2025 M2D2 $200K Challenge, receiving $50,000 in seed funding from the Massachusetts Life Sciences Center plus in-kind consulting support.
Latest developments
In March 2025 CranioSense won first place at the M2D2 $200K Challenge finals at UMass Lowell, announced in April 2025, earning $50,000 in seed funding from the Massachusetts Life Sciences Center and in-kind support from consulting firm bene : studio. A pilot validation study of its diagnostic algorithm at Massachusetts General Hospital was ongoing with anticipated completion in August 2025.
▸Full profile — market position, technology, go-to-market, geography, history
Market position
Early-stage entrant pursuing non-invasive intracranial pressure measurement, an application clinicians quoted by the company describe as an unmet need relative to invasive ICP monitoring.
Avoids the skull drilling and intracranial sensor placement required by current ICP monitoring, using an external forehead patch and handheld reader intended for use earlier in the care pathway and in pre-hospital settings.
Technology
The system uses a forehead patch with two clip-on sensors connected to a handheld device to derive intracranial pressure non-invasively. Development has drawn on near-infrared algorithm expertise, with a proprietary diagnostic algorithm developed and optimized using data from seven ICU sites in the United States, using external ventricular drain and bolt measurements as ground truth. A completed healthy-human study established correlation between pulse transit time and ICP, and a completed ICU study compared the approach directly to the ICU gold standard.
Go-to-market
Clinicians managing patients with suspected elevated intracranial pressure, including neurointensivists, neurosurgeons, emergency department neurologists, community and rural hospitals, and pre-hospital providers such as paramedics.
Geography
Headquartered in Bedford, Massachusetts, with clinical studies and physician engagement across the United States, including ICU sites, Massachusetts General Hospital neuroradiology, and clinician collaborators in Texas, Florida, Tennessee and New Hampshire.
History
The company was founded in Bedford, Massachusetts, by Gordon Hirschman, Ryan Myers and Kristian DiMatteo, licensing technology from Vivonics, Inc. It advanced from healthy-human feasibility work through an ICU gold-standard comparison across seven US sites and into a pilot validation study, and in March 2025 it won first place in the M2D2 $200K Challenge finals held at UMass Lowell.
Compiled by commissioned research from 6 cited public sources — announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed — not independently audited.
Competitors · 2
by search overlap
Companies competing with CranioSense for the same Google search keywords, organic and paid, via search-intersection analysis.
Timeline · 3
launches, deals, and filingsCranioSense was named top winner of the Massachusetts Medical Device Development Center $200K Challenge, whose finals were held at UMass Lowell on March 26, 2025, out of entrants from more than 175 companies across 12 countries and 22 US states. The prize included $50,000 in seed funding from the Massachusetts Life Sciences Center and in-kind support from consulting firm bene : studio.
$50K source ↗
Completed study comparing the CranioSense measurement to the ICU gold standard across seven US ICU sites using external ventricular drain and bolt ground truth, reporting high correlation and supporting algorithm development.
Ongoing pilot validation of CranioSense's proprietary algorithm with neuroradiology at Massachusetts General Hospital, validated against lumbar puncture opening pressure as ground truth, n=30, with anticipated completion in August 2025.
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
In the news
▸Research sources · 6
primary sources listed
- CranioSensecraniosense.com · web
6 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does CranioSense do?
- Clinical-stage medical device company developing a non-invasive system to measure intracranial pressure.
- Who founded CranioSense?
- CranioSense was founded by Gordon Hirschman, Ryan Myers, Kristian DiMatteo in 2022.
- Who are CranioSense's investors?
- CranioSense's investors include Illinois Ventures, Techstars.
- Where is CranioSense headquartered?
- CranioSense is headquartered in Bedford, US.