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AURA Health – Fertigung

Develops AI-based ultrasound software for localizing biopsy markers in breast cancer care.

AURA Health Logo

AURA Health Technologies GmbH

Berlin (Kurfürstendamm 188/189, 10707)New on Amplifa

2021Founded
11–50Employees
BerlinHeadquarters
HRB 221676 B, Amtsgericht CharlottenburgCommercial Register

About AURA Health Technologies

AURA Health Technologies GmbH is a medical technology company founded in Berlin in 2021 that develops AI-based ultrasound software for breast cancer care. The software uses machine learning to interpret ultrasound images in real time, automatically localize biopsy markers (clips), and visualize tumor margins – with the aim of dispensing with additional localization instruments such as wires or marker seeds. Another focus is ML-based image quality improvement, including automatic correction of device differences and guidance for optimized user behavior. The solution is being clinically validated together with hospitals and research institutions; market entry in Europe and the USA is in preparation, and an FDA submission is underway. The interdisciplinary team in Berlin works at the intersection of medical imaging, artificial intelligence, and software as a medical device. In the funded project “Next Level Ultrasound” (IBB ProFIT, co-financed by ERDF), the algorithm, the data basis, and quality and safety standards are being further developed.

Site
Berlin
Processes
AI-based ultrasound software for localizing biopsy markers, ML-based image quality improvement, Clinical validation with hospitals and research institutions
Materials
Machine Learning / Image Processing, ML-Based Image Quality Improvement, Software as a Medical Device
Founded
2021
Employees
11–50
Industries
Medical Technology, Breast Cancer Diagnostics and Surgery, Medical Imaging, Software as a Medical Device
  1. 01

    Software development (AI/ML algorithms)

  2. 02

    Building and curating image databases

  3. 03

    Clinical validation with hospitals and research institutions

  4. 04

    Quality management and regulatory affairs (including FDA submission)

Technologies and Processes

ML

Machine Learning / Image Processing

Real-time interpretation of ultrasound images for automatic detection of common biopsy markers regardless of their shape.

IQ

ML-Based Image Quality Improvement

Automatic correction of device differences and guidance for optimized user behavior, also for less trained staff.

SaMD

Software as a Medical Device

Software for intraoperative support of tumor localization, developed according to relevant quality and safety standards.

Locations

Berlin

DE

Headquarters: development, quality management, sales

Inside the production

Vision of AURA Health Technologies
Vision of AURA Health Technologies

Industries

Medical TechnologyBreast Cancer Diagnostics and SurgeryMedical ImagingSoftware as a Medical Device

Additional services

AI-based ultrasound software for localizing biopsy markersML-based image quality improvementClinical validation with hospitals and research institutions

Reference customers

Hospitals, research institutions and industry partners (not publicly named)

History

  1. 2021

    Founded in Berlin

  2. 2025

    Launch of the IBB ProFIT funded project “Next Level Ultrasound” (01.01.2025–31.03.2027, co-financed by ERDF/IBB)

  3. 2025

    Presence at RSNA 2025 in Chicago; FDA submission in preparation

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