Neolook Solutions has received CE marking for EarlyMoves under EU MDR 2017/745, certifying the world's first home-assessment General Movement Assessment (GMA) solution for unmonitored home use. The certification completes a four-year bedside-to-breakthrough cycle from NICU co-design to MDR-grade clinical device.
EarlyMoves was developed from the ground up in co-design with the neonatal intensive care unit at UMCG (University Medical Center Groningen), the Netherlands' leading neonatal referral centre. The product enables parents to record standardised GMA assessments of their infant at home, with results processed through Neolook's validated AI classification engine. Early detection of neuromotor abnormalities — including signs of cerebral palsy — within the first months of life enables earlier intervention and improved developmental outcomes.
Clinical validation was conducted across a multi-site cohort with UMCG as the primary study site. The validation data underpins the MDR technical dossier submitted for CE marking under Class I, Rule 11.
Following CE certification, UMCG initiated a sole-respondent procurement process for EarlyMoves, citing absence of equivalent CE-certified alternatives in the European market. The sole-respondent designation confirms EarlyMoves' position as the only MDR-certified home-assessment GMA solution available in the EU.
A multi-hospital deployment pipeline is now active, with discussions underway at neonatal centres across the Netherlands and Belgium. The EU Interreg NWE programme recognised EarlyMoves as part of the broader NICU-to-home pathway innovation.
For investors, the CE marking closes the EarlyMoves bedside-to-breakthrough cycle and establishes a structural first-mover position in the EU home-assessment GMA segment. Combined with the sole-respondent UMCG procurement, the certification creates a clinical and regulatory moat that is reinforced with each additional hospital deployment.