Carelog AI

We Secured a Breakthrough Device Designation for a ECG Foundation Model

Reframed regulatory strategy after FDA pushback. BDD granted in ~3 months.

Aman Aman

We likely wouldn't have received our Breakthrough Device Designation without Innolitics. When FDA initially pushed back, they quickly understood the concerns and responded with clear, well-supported data. Their expertise in software, medicine, and FDA's AI/ML expectations made a decisive difference in the outcome.

Aman AmanFounder, Carelog AI
ClientCarelog AIMedical areaCardiologyBreakthrough Designation in 2 WeeksFDA Strategy & Pre-Sub in 4 WeeksAI/ML

FDA said no. We got them to yes in 90 days.

The Result

FDA granted Breakthrough Device Designation for Diastolytix on October 9, 2024.

The Device

Diastolytix screens for Grade 3 diastolic dysfunction using standard ECGs, replacing the need for echocardiography. Millions go undiagnosed because echo requires skilled sonographers and cardiologists with advanced training.

The Challenge

Carelog came to Innolitics confident their device met FDA criteria for Breakthrough Device Designation. Innolitics prepared and submitted the request.

FDA pushed back, questioning whether Diastolytix truly met the "more effective treatment or diagnosis" standard.

What Innolitics Did

The team didn't accept no. Within days:

  1. Repositioned the value proposition: Shifted from competing with echocardiography to serving patients who'd otherwise get no diagnosis at all. Flipped FDA's objection into a strength.
  2. Quantified the gap: Data-mined ICD codes for asymptomatic heart failure and located NIH research showing rural ultrasound access disparities.
  3. Framed for health equity: Emphasized that Diastolytix uses commonly available ECG devices, benefiting underserved populations impacted by healthcare disparities. Differentiated from Ultromics' EchoGo (which requires echo images) by positioning as a complementary frontline screening tool.

Timeline

Date Milestone
Jul 12, 2024 Contract signed
Jul 16, 2024 Initial BDD document shared
Aug 9, 2024 Q-SUB submitted to FDA
Sep 12, 2024 FDA pushback response with health equity framing
Oct 9, 2024 BDD granted

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