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Romanian startup seeks R&D partners for certification and novel usecase development of a Class IIb AI-based digital mental health device

Summary

Profile Type
  • Business request
POD Reference
BRRO20250617014
Term of Validity
23 June 2025 - 23 June 2026
Company's Country
  • Romania
Type of partnership
  • Commercial agreement
Targeted Countries
  • All countries
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General information

Short Summary
A Romanian startup developing an AI-powered digital therapeutic platform for psychosis detection and auditory hallucination management seeks international R&D partners to support certification as a Class IIb medical device and codevelop novel use cases in defense, trauma care, and space applications.
Full Description
GOBLIN AI SRL is a Romanian startup founded in 2023, focused on delivering intelligent digital health solutions targeting mental health challenges in extreme or isolated environments. Its flagship innovation, the GOBLIN platform, combines eye-tracking, large language models (LLMs), and Avatar Therapy principles to detect and manage auditory hallucinations and psychotic episodes in real-time.
The company now seeks international research and development partners for two main objectives:
1. To support GOBLIN’s path to CE certification as a Class IIb medical device under the EU Medical Device Regulation (MDR), focusing on risk classification, clinical evidence collection, usability testing, and documentation for regulatory
approval.
2. To co-develop new use cases for GOBLIN’s modular and AI-based architecture in critical environments such as:
- Military and defense applications (PTSD, isolation-induced psychosis)
- Space medicine (astronaut psychological support in long-duration missions)
- Maritime or polar missions (remote resilience interventions)
- Emergency trauma therapy (acute psychosis and hallucination mitigation)
- Digital biomarkers for neuropsychiatric diagnostics
The partners will collaborate with GOBLIN AI on use-case validation, clinical scenario testing, and will be invited to join
future Horizon Europe and ESA-aligned consortia.
Advantages and Innovations
- Combines multiple AI technologies: eye-tracking, LLMs, and digital avatars
- Addresses early detection and real-time mitigation of psychosis symptoms
- Designed for use in inaccessible or high-stress environments (space, defense, maritime)
- Modular system for remote updates and integration with biometric wearables
- Supports non-invasive, autonomous interventions outside traditional healthcare facilities
- Readiness to evolve into a Class IIb CE-certified digital therapeutic
Technical Specification or Expertise Sought
We are looking for partners with expertise in any of the following:
- Medical device certification under MDR, especially for Class IIb devices
- Digital mental health interventions, e.g., AVATAR Therapy, CBTp, EMDR
- Clinical trials and usability studies involving AI-based tools
- Human factors engineering, user interaction in neurodigital interfaces
- Space medicine, defense mental health, or trauma care innovation
- Regulatory science and digital biomarker validation
- Semantic AI or AI model alignment for patient safety in LLMs
The ideal partner should be able to co-develop validation protocols, contribute to technical documentation for CE/MDR, and explore integration with existing clinical or operational workflows.
Stage of Development
  • Lab tested
Sustainable Development Goals
  • Goal 3: Good Health and Well-being
  • Goal 9: Industry, Innovation and Infrastructure
  • Goal 16: Peace and Justice Strong Institutions
IPR status
  • IPR applied but not yet granted

Partner Sought

Expected Role of a Partner
- Identification and piloting of novel use cases
- Joint development of testbeds for resilience, psychotrauma, or remote behavioral health
- Potential participation in EU-funded research proposals
Type and Size of Partner
  • SME 50 - 249
  • University
  • R&D Institution
  • SME 11-49
  • SME <=10
Type of partnership
  • Commercial agreement

Dissemination

Technology keywords
  • 06001014 - Neurology, Brain Research
  • 01003022 - Smart Appliances
  • 01003003 - Artificial Intelligence (AI)
  • 06001005 - Diagnostics, Diagnosis
  • 01003018 - User Interfaces, Usability
Market keywords
  • 05003006 - Other therapeutic (including defibrillators)
  • 05001007 - Other diagnostic
  • 05006 - Anatomy, Pathology, Immunology, Physiology
  • 05005022 - Other clinical medicine
  • 05007007 - Other medical/health related (not elsewhere classified)
Targeted countries
  • All countries