We helped a University Spinout go from Prototype to Acquisition.

We secured breakthrough status and drove a 3-month FDA submission for an AI breast-risk SaMD.

Shu (Joy) Jiang, PhD

Before working with Innolitics, I struggled to find a partner who understood both AI regulatory requirements and the cybersecurity expectations our device needed to meet. I spoke with several consultants, but none could cover the full scope. Every option seemed to push more work back on us, and the whole thing was starting to feel like a “do it yourself” regulatory project. If we had stayed on that path, we would have missed a narrow window of opportunity. Competitors were moving fast, and delaying our regulatory plan would have given them room to enter the market first and capture early share. Innolitics changed the trajectory. They built our regulatory strategy, prepared the pre-submission, and helped us secure Breakthrough Device Designation.

Shu (Joy) Jiang, PhDCo-Founder of Prognosia Breast (acquired by Lunit)
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Graham A. Colditz, MD, DrPH

We came to Innolitics with a novel AI prognostic tool for breast cancer risk assessment and little clear regulatory path. Within weeks, they submitted a presub and a breakthrough device designation, both which added clarity to our clinical validation strategy and granted us breakthrough designation respectively. The team identified that our device would need to go the De Novo route and walked us through every implication. But they didn't stop there. They saw the potential for Breakthrough Device Designation and built a compelling case for why our technology met FDA's criteria. The quality of that submission was exceptional, thoroughly researched, clearly argued, and backed by deep knowledge of AI/ML regulatory precedents. The Pre-Sub process was where Innolitics really proved their value. They prepared our Q-Submission package, coordinated with FDA, and ran the meeting with us. FDA's feedback was direct and actionable, which meant we weren't wasting time or money chasing the wrong pathway. That alone saved us months and probably six figures in misdirected effort. What impressed us most was how they handled complexity without creating confusion. They reviewed our clinical protocols, identified gaps in our validation datasets, helped us understand special controls for De Novo submissions, and gave us a realistic timeline for market access. Every deliverable was thorough, on time, and written in a way that both our clinical team, business stakeholders, and FDA could understand.

Graham A. Colditz, MD, DrPHCo-Founder of Prognosia Breast (acquired by Lunit)
Terri Kim

We came to Innolitics with a complex AI/ML CADx algorithm and an aggressive timeline. Honestly, we weren't sure it was possible.
Yujan and the Innolitics team turned that assumption upside down. Through their leadership, the combined Innolitics, Lunit, and Volpara Health team delivered a complete submission package—DHF, software documentation, clinical performance assessment, the full eSTAR—in 13 weeks!
What impressed me most wasn't just the speed. It was how they handled the complexity—both technical and organizational. Our device uses AI algorithms for diagnosis, which presented unique regulatory challenges. We also had a multi-national, cross-functional team that needed coordination across time zones and disciplines.
The Innolitics team managed all of it. They knew exactly how to position the device, which predicates to target, and how to draw the medical device versus MDDS boundaries in a way that held up under scrutiny. Most importantly, they structured the technical documentation so FDA reviewers could actually understand what we built without getting lost in the ML weeds.
That combination—deep regulatory knowledge, technical fluency, and the ability to keep a complex team moving in the same direction—is rare. Most consultants have one or two of those. Innolitics have all three. They didn't cut corners. Every deliverable was thorough, well-written, and backed by their deep knowledge of medicine, software engineering, and FDA expectations.
If you've got a sophisticated AI/ML device and need full service regulatory expertise that moves at the speed and certainty, Innolitics is the only call worth making.

Terri KimTerri Kim, Head of Strategy and Corporate Development at Lunit
ClientMedical areaRadiologyFDA Strategy & Pre-Sub in 4 WeeksAI/ML510k

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.

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