US-based digital health company Sandstone Diagnostics has secured 510(k) clearance from the Food and Drug Administration (FDA) for its Trak Male fertility testing system.
The Trak in-home test allows couples to monitor sperm counts, ensuring privacy when they plan to conceive.
Sandstone CEO Greg Sommer said: "This FDA clearance represents a monumental milestone for Sandstone Diagnostics as we prepare to launch Trak as a radically new approach to personal fertility management.
"Male infertility is a dramatically under-appreciated condition affecting millions of couples every year.
"Trak is a complete system that not only gives couples the ability to conveniently measure semen quality at home, but also provides digital health tools and population-based data to help men take charge of their reproductive health in a whole new way."
The device uses a centrifugal force to classify and calculate sperm cells using specially designed disposable cartridges.
Trak Engine and several disposable test kits constitute the equipment and allow repeat testing.
The fully integrated Trak System digital health system also accompanies the Trak mobile application.
The pairing enables men to enter, track and compare their results to population statistics through the cloud-based community of users and clinical databases while receive personalised feedback on lifestyle and wellness steps that may increase their sperm count.
The company noted Trak is the first FDA-approved device to classify sperm count as low, moderate or optimal aligned with the World Health Organisation (WHO) guidelines and clinical studies that correlate higher sperm counts with faster time to pregnancy.