---
ai_summary: "\\- Partnered with BEACON-Neuro.AI, a Washington University in St. Louis\
  \ startup, on BEACONPredict, AI software predicting malignant cerebral edema risk\
  \ after acute ischemic stroke.  \n- Provided regulatory strategy and software engineering;\
  \ De Novo pathway as a clinical decision support tool.  \n- FDA Breakthrough Device\
  \ Designation granted on the first review cycle, plus acceptance into FDA\\'s TAP\
  \ pilot."
case_study_510ks: []
client_logo:
- 3cbbd5b7-a754-81f2-86fe-c199968cfa90
client_name: BEACON-Neuro.AI - Dr. Raj Dhar
date: '2026-08-29'
featured: true
medical_panel: Neurology
name: From Lab Code to FDA Breakthrough Device
services:
- 2c7bd5b7-a754-804a-8419-c2f3affb5a69
- 28abd5b7-a754-80f8-a6fb-c5adc4aa8993
- 9dc4f55a-b5cb-419f-8bae-5e11d6b11fee
summary: Regulatory strategy and engineering that took BEACONPredict from research
  prototype to FDA Breakthrough Device
tags:
- AI/ML
testimonials:
- 3cbbd5b7-a754-81e9-b699-e994956ac8b5
---

### The Problem

Malignant cerebral edema is a life-threatening complication after a large ischemic stroke, and catching it early is one of the harder calls in neurocritical care. A care team that sees it coming can escalate monitoring or move to decompressive surgery before irreversible deterioration sets in.

BEACON-Neuro.AI Inc., a Washington University in St. Louis startup built on the clinical science of Dr. Raj Dhar\'s neurocritical-care lab at WashU Medicine, developed BEACONPredict: AI software that analyzes early brain-imaging changes alongside clinical variables and returns a risk estimate that supports the clinician\'s decision-making. The science was ready. What the team needed was an FDA-accepted route from research prototype to medical device --- expertise outside a research lab.

### The Outcome

- FDA Breakthrough Device Designation granted on the first review cycle.
- Acceptance into FDA\'s TAP pilot, providing enhanced FDA engagement and a potentially accelerated CMS NTAP reimbursement pathway after marketing authorization.
- A De Novo pathway underway, positioning BEACONPredict as a clinical decision support tool.
- BEACONPredict advanced from lab code to FDA Breakthrough Device in a single submission cycle.

<div class="pl-3 border-solid border-0 border-l-4 border-gray" custom-style="Block Quote" markdown="1" role="blockquote">

We developed the science at WashU Medicine, but reaching patients requires FDA clearance --- outside research lab expertise. Partnering with Innolitics, we advanced BEACONPredict from lab code to FDA Breakthrough Device in one submission cycle.  
--- Raj Dhar, MD, Co-Founder, BEACON-Neuro.AI; Professor of Neurology, WashU Medicine

</div>

### The Timeline

- Engagement: Innolitics provided regulatory strategy and software engineering; BEACON-Neuro.AI contributed the clinical science.
- First review cycle: FDA granted Breakthrough Device Designation with no additional review cycles needed.
- Now: De Novo classification underway, with TAP pilot engagement. BEACON-Neuro.AI is raising pre-seed and seed funding to carry BEACONPredict through FDA clearance and commercial launch.

### The Solution

Breakthrough Device Designation on the first attempt is not a matter of good science alone --- it comes from aligning the clinical evidence plan and the regulatory strategy before anything is submitted. Innolitics established the De Novo route as a clinical decision support tool, planned the clinical and regulatory story as one document set, and engineered the software to match.

<div class="pl-3 border-solid border-0 border-l-4 border-gray" custom-style="Block Quote" markdown="1" role="blockquote">

BEACON-Neuro.AI brought new science addressing an unmet clinical need. Our role was establishing an FDA-accepted route, achieving designation on the first review cycle through aligned clinical and regulatory planning.  
--- Yujan Shrestha, MD, Partner, Innolitics

</div>

*Breakthrough Device Designation is a premarket program, not a marketing authorization; BEACONPredict is not yet cleared or approved for commercial distribution.*

Read the full announcement: [Innolitics and BEACON-Neuro.AI Partner to Bring FDA Breakthrough Device BEACONPredict to Market](https://www.businesswire.com/news/home/20260828456775/en/Innolitics-and-BEACON-Neuro.AI-Partner-to-Bring-FDA-Breakthrough-Device-BEACONPredict-to-Market)

<figure>
  <img src="/img/portfolio/From_Lab_Code_to_FDA_Breakthrough_Device-3cbbd5b7a75481e99d32f4b047a8c343.png">
  <figcaption>
    BEACONPredict began as research at Washington University in St. Louis
  </figcaption>
</figure>