Regulatory review in progress
On the path to clinical use
Delian is being developed through a structured clinical, engineering, quality, and regulatory program, with a development effort designed to support an FDA 510(k) submission for noninvasive cerebral perfusion monitoring.
Until approval is granted, Delian is available for research use only. We are working with research institutions now so that, once approved, the device arrives in clinical practice with the evidence and protocols teams need.
Regulatory pathway
The 510(k) pathway for cerebral perfusion monitoring
What is a 510(k)?
A regulatory pathway used by the FDA to evaluate whether a new medical device is substantially equivalent to an existing legally marketed device.
Why this pathway?
Cerebral perfusion monitoring devices already have established regulatory classifications. Delian's near-infrared optical approach maps to existing predicate devices in the noninvasive cerebral oximetry and perfusion monitoring category.
FDA 510(k) Pathway Overview
New Device
Delian cerebral perfusion monitor
510(k) Submission
Substantial equivalence claim
FDA Review
Predicate device comparison
Clearance
Commercial distribution
Delian is currently in the verification & validation stage, prior to 510(k) submission.
Development progress
A clear path from concept to submission
Delian is being advanced along a defined development path, from identifying the clinical need to 510(k) submission and FDA review. Delian is currently progressing through the verification, validation, and safety-testing stages, with submission assembly planned following key electrical safety and EMC milestones.
Clinical Need
Identified target indication and patient population
Product Definition
Device specifications and intended use established
Verification & Validation
Active V&V testing underway
Safety & EMC Testing
Electrical safety and electromagnetic compatibility
510(k) Submission
Assembly and filing with FDA
FDA Review
Substantial equivalence determination
Current status
Current status and future availability
Delian is a medical device in development, has not been FDA cleared, and is not available for commercial sale. Final indications and specifications are subject to change during development and FDA review.
Built for the moments perfusion matters most
Clinical studies in stroke
In stroke, minutes decide outcomes. Delian measures left and right cerebral blood flow side by side in real time, giving researchers a fast, repeatable perfusion measure they can take at the bedside, in the emergency department or in transit.
Surgical monitoring
Cardiac, vascular and neurosurgical procedures can change blood flow to the brain without warning. Delian is designed to track cerebral perfusion continuously throughout a procedure, so changes show up as they happen rather than after.
Post-surgery monitoring
The hours and days after surgery carry their own risks. Delian is light and wearable, made for continuous monitoring in recovery and intensive care, where an early sign of falling perfusion gives the care team time to respond.
Noninvasive
Low-intensity near-infrared light reads perfusion through the skin and skull. No injections, contrast or radiation.
Continuous
40 readings per second, for as long as the study runs.
Bilateral
Left and right hemispheres measured at the same time, so asymmetry is visible immediately.
Portable
A wearable sensor and compact console that go to the patient, not the other way round.
Plan a study with Delian
We're partnering with stroke centers, surgical teams and critical care units now. Tell us about your study.
Delian is not yet approved for clinical use. For Research Use Only. Not for use in diagnostic procedures.