---
AI Summary: "\\- Prepared and submitted FDA Pre‑Submission and Breakthrough Device\
  \ Designation for Prognosia Breast AI/ML SaMD.  \n- Re‑engineered regulatory strategy\
  \ using DeNovo framework and Clairity Allix5 predicate.  \n- Executed accelerated\
  \ FDA submission within 3‑month window, securing TAP access and final acquisition."
Anonymous: false
Assignee:
- Yujan Shrestha
Last Edited Time: '2026-05-10T23:23:00+00:00'
case_study_510ks: []
client_logo:
- 35cbd5b7-a754-801b-9431-c8e717955585
client_name: University spinout acquired by global AI company
date: '2026-05-10'
featured: true
medical_panel: Radiology
name: We helped a University Spinout go from Prototype to Acquisition.
services:
- 28abd5b7-a754-80f8-a6fb-c5adc4aa8993
- 6d5e46e7-72da-4217-bdd9-c1c771f2f696
summary: We secured breakthrough status and drove a 3-month FDA submission for an
  AI breast-risk SaMD.
tags:
- AI/ML
- 510k
testimonials:
- 35cbd5b7-a754-817c-b38f-c9681c6d0a16
- 35cbd5b7-a754-81b1-8b99-f2e258cc78e4
- 2a6bd5b7-a754-80d2-983a-cfb611c88717
---

## The Outcome

Breakthrough Device Designation granted. TAP program access granted. Company acquired by Lunit. FDA submission completed inside the guaranteed 3-month window before RSNA.

## The Problem

Washington University had developed a prognostic AI/ML SaMD for breast cancer risk assessment, but the regulatory path was not straightforward. FDA did not accept the original predicate strategy and asked hard questions about intended use, clinical workflow, output format, population representativeness, train/test independence, final device alignment, and ground-truth quality.

That framing mattered. This was not a conventional CADe device. Prognostic software has a different evidentiary burden: calibration, absolute risk, longitudinal outcomes, and the clinical meaning of a risk category all sit at the center of the submission.

Then the business context changed. Prognosia became the commercial vehicle, Lunit acquired the asset, and the work shifted from early regulatory strategy into accelerated submission execution. The team needed to preserve FDA momentum, respond through TAP, adapt to the emerging Clairity Allix5 predicate, and prepare a submission-ready package without exposing proprietary raw data or model weights.

## What We Did

- Prepared and submitted the initial FDA Pre-Submission for Prognosia Breast.
- Reframed the regulatory strategy after FDA concluded the original predicate path was not acceptable.
- Built the Breakthrough Device Designation request and submitted the final package to FDA.
- Helped secure Breakthrough Device Designation for Prognosia Breast.
- Supported TAP participation after Lunit acquired Prognosia Breast.
- Refined the intended use, output format, clinical validation endpoints, and labeling language against the newly relevant Clairity Allix5 De Novo precedent.
- Guided the clinical performance strategy around absolute risk, categorical outputs, calibration, U.S. population representation, and study design.
- Supported the accelerated FDA submission workstream for Lunit/Prognosia, including device description, DHF review, clinical performance strategy, report labeling, and submission collation.
- Completed the submission inside the guaranteed 3-month window for a non-trivial computer-aided prognosis device.

## Highlights

| Milestone               | Result                                                                                                                           |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Initial FDA interaction | Pre-Submission Q242599 for Prognosia Breast                                                                                      |
| Regulatory pathway      | FDA feedback moved the strategy away from the originally proposed 510(k) predicate approach and toward a De Novo-style framework |
| Breakthrough status     | Breakthrough Device Designation granted                                                                                          |
| FDA access              | TAP participation pursued after Lunit acquired Prognosia Breast                                                                  |
| Submission execution    | FDA submission completed before RSNA, inside the guaranteed 3-month window                                                       |

## Timeline

- **October 2024** --- Initial Pre-Submission submitted for Prognosia Breast.
- **December 2024** --- FDA Pre-Submission meeting held for Q242599.
- **April 2025** --- Breakthrough Device Designation request submitted.
- **June 2025** --- Prognosia Breast granted Breakthrough Device Designation.
- **August 2025** --- Lunit/Prognosia accelerated submission workstream underway; report labeling and validation strategy refined.
- **November 2025** --- FDA submission completed before RSNA, within the guaranteed 3-month timeline.