---
AI Summary: "\\- Repositioned Diastolytix\\'s value from competing with echocardiography\
  \ to addressing undiagnosed patients.  \n- Utilized standard ECGs, allowing broader\
  \ access.  \n- Emphasized health equity by highlighting disparities in rural ultrasound\
  \ access.  \n- Achieved Breakthrough Device Designation from the FDA in 90 days."
Anonymous: false
Assignee: []
Last Edited Time: '2026-01-26T01:07:00+00:00'
client_logo: []
client_name: Carelog AI
date: '2026-01-25'
featured: false
medical_panel: Cardiology
name: We Secured a Breakthrough Device Designation for a ECG Foundation Model
services:
- 2c7bd5b7-a754-804a-8419-c2f3affb5a69
- 28abd5b7-a754-80f8-a6fb-c5adc4aa8993
summary: Reframed regulatory strategy after FDA pushback. BDD granted in \~3 months.
tags:
- AI/ML
testimonials:
- 3a42b9bd-d096-46da-a2c9-9b808be073da
---

**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**                                  |