Maternal wearable device Oli has completed patient recruitment for its fourth and final clinical trial prior to TGA and FDA submission, successfully enrolling 1,000 mothers across seven hospital sites in Australia and the United States.
Oli is a wireless, wearable device that captures millions of physiological data points across 10 biosensors – maternal and fetal, simultaneously – without interrupting movement, position, or the natural progression of labour.
The milestone comes ahead of regulatory submissions as Oli progresses toward commercial launch. The trial is evaluating Oli’s first clinical application, postpartum haemorrhage (PPH), one of the leading causes of maternal death globally.
Oli reached full enrolment of 1,000 mothers in approximately six months, reflecting both strong clinician support and positive patient acceptance of the technology.
Clinicians have adopted Oli into existing maternity workflows with ease, while mothers have responded positively to Oli’s design which enables comfortable monitoring without interruption or restriction of movement, supporting a wider range of birthing environments including time in water.
Oli Director of Clinical Operations Bernadette Pickering said, “Clinical trials are ultimately about patients. Every woman who has chosen to participate in this pivotal study is helping shape the future of maternal care and we’re incredibly grateful for the trust they’ve placed in us. The commitment and dedication from all our sites to recruit so quickly shows us how clinician and patient friendly Oli truly is.”
Results from the pivotal clinical trial are expected in the coming months. Participating hospitals include: Columbia University Irving Medical Center (New York City, New York State), University of Pittsburgh Medical Center – UPMC Magee-Women’s Hospital (Pittsburgh, Pennsylvania), The Ohio State University Wexner Medical Center (Columbus, Ohio), University of Colorado Anschutz Medical Campus (Denver, Colorado), Woman’s Hospital (Baton Rouge, Louisiana), Royal North Shore Hospital (Sydney, Australia) and The Royal Hospital for Women (Sydney, Australia).
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