From Lab Code to FDA Breakthrough Device

Regulatory strategy and engineering that took BEACONPredict from research prototype to FDA Breakthrough Device

Raj Dhar, MD

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, MDCo-Founder of BEACON-Neuro.AI and Professor of Neurology at WashU Medicine
ClientMedical areaNeurologyBreakthrough Designation in 2 WeeksFDA Strategy & Pre-Sub in 4 WeeksSoftware DevelopmentAI/ML

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.

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

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.

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

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

Celebrating the Win

A milestone like this deserves more than a quiet page on our website. To celebrate BEACON-Neuro.AI's success, Innolitics sponsored and coordinated a joint press release. Our announcement ran on Business Wire: Innolitics and BEACON-Neuro.AI Partner to Bring FDA Breakthrough Device BEACONPredict to Market (August 28, 2026).

The announcement was picked up by outlets including Yahoo Finance, Morningstar, the Times Argus, the Rutland Herald, and PortalERP.

We do this with our clients: when you share your story with us in a case study like this one, Innolitics sponsors and coordinates a joint press release celebrating your success. If you have a milestone worth announcing, we would love to tell the story with you.

BEACONPredict began as research at Washington University in St. Louis

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