SpermSearch.AI is now included in the ARTG
We are pleased to announce that SpermSearch.AI has been included in the Australian Register of Therapeutic Goods (ARTG) under ARTG No. 528777. SpermSearch.AI is now available for supply in Australia, and Australian IVF clinics can access it as part of their andrology and embryology workflows.
For the teams who spend their days at the microscope, and for the patients relying on them, it means a purpose-built tool is now available through the same national register that governs medical devices supplied across Australia.
The clinical challenge
Locating sperm in cases of severe male factor is one of the most labour-intensive tasks in the IVF laboratory. In cases including cryptozoospermia and samples recovered through surgical sperm retrieval, an embryologist may need to search through large volumes of material to find a small number of viable sperm.
The work is meticulous, time-intensive, and cognitively taxing. It often falls to the most experienced staff, and the result can shape a couple's entire treatment pathway. When every sperm counts, the pressure on the search is considerable.
How SpermSearch.AI helps
SpermSearch.AI applies real-time artificial intelligence to assist embryologists and andrologists as they search. Built on real-time object detection, it identifies and localises sperm within the field of view as the operator works, highlighting candidates so they can be assessed and recovered.
The embryologist remains fully in control of every clinical decision. SpermSearch.AI is designed to support the search, not to replace the expertise and judgement of the laboratory team. By easing the manual burden of visual searching, it aims to help laboratories work more efficiently and consistently, particularly in the challenging cases that demand the most time and attention.
What inclusion in the ARTG means
Inclusion in the ARTG means SpermSearch.AI meets the applicable Australian regulatory requirements for supply as a medical device. For clinics, it means the tool can be adopted with the confidence that comes from a device carried on the national register, supported by NeoGenix's quality management system and an ongoing program of post-market surveillance.
Regulatory status
SpermSearch.AI is included in the Australian Register of Therapeutic Goods (ARTG No. 528777) and is available for supply in Australia. It is intended to assist trained embryologists and andrologists in the identification of sperm and does not replace clinical judgement.
Looking ahead
ARTG inclusion is one milestone within a broader regulatory roadmap for SpermSearch.AI that extends to further international markets. We will keep working alongside clinics, embryologists, and andrologists to bring dependable AI assistance into everyday practice, and to support the teams doing some of the most difficult work in the fertility laboratory.
