Owlet announced that its flagship Dream Sock has received approval from Australia’s Therapeutic Goods Administration (TGA), enabling the medical‑grade infant monitor to be sold in Australia and New Zealand. The approval, announced on December 5 2025, removes a key regulatory hurdle and opens a new distribution channel for the company.
The Dream Sock, which tracks pulse rate, oxygen saturation and sleep trends for infants aged 0‑18 months, has already earned FDA clearance in the United States. With the TGA certification, the device now meets the stringent safety and performance standards required in the Australian and New Zealand markets, giving parents and clinicians confidence in its accuracy.
While the original article cited an annual birth figure of 140 million for the region, that number applies to the global market. In Australia and New Zealand combined, there were just over 300 000 births in 2024, meaning the addressable customer base is far smaller than the figure suggested. Nevertheless, the company expects the new markets to contribute a modest but growing share of its revenue as it expands its Owlet360 subscription service.
Owlet’s CEO Jonathan Harris said the expansion “represents a meaningful step in our international growth strategy, as parents in Australia and New Zealand are actively seeking trusted, medically‑validated solutions.” The company’s first quarterly operating profit in Q3 2025 and strong revenue growth give it the financial flexibility to invest in the subscription platform, which is projected to become a higher‑margin recurring revenue stream.
Analysts note that the TGA approval positions Owlet ahead of competitors such as Nanit and Snuza, which lack medical‑grade certifications. The company’s data‑driven insights, powered by its 2.5 million‑baby dataset, will also support future clinical partnerships in the region, potentially opening new revenue channels beyond consumer sales.
The launch will be supported by a local website and select retail partners, and Owlet plans to roll out its Owlet360 subscription in the region over the next 12 months. The company’s guidance for the remainder of 2025 remains unchanged, but management signals confidence that the new markets will help sustain growth momentum.
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