Optiscan Submits FDA Dossier for Inspecta Imaging Device Targeting Lucrative US Veterinary Market

Optiscan has submitted a regulatory dossier to the US Food and Drug Administration (FDA) regarding its InSpecta digital microscopic imaging device for animal health, marking a key step towards entry into the US veterinary market.

The submission brings together the full body of work completed on InSpecta to date, including how the device is designed, how it is used within veterinary workflows, and the data generated through testing and validation.

It moves the portable device into formal regulatory review, supporting the expansion of clinical reference sites and strengthening the company’s engagement with veterinary customers and partners.

It also establishes a regulatory standard and process that can be applied to future devices across the Optiscan portfolio.

Key Development Step

The FDA submission marks an important step in Optiscan’s development journey and is a key step in bringing any medical device into the US—a clear regulatory pathway will give the company greater confidence to progress discussions with potential customers, partners, and distributors.

The process demonstrates the company’s ability to move a device from concept and development into regulatory review, with approval paving the way for commercial marketing, sales, and usage in the region’s lucrative veterinary market.

InSpecta was launched in mid-2025 as Optiscan’s first device designed specifically for the veterinary medicine market which, in the US alone, was valued at approximately US$11.92 billion in 2022 and is projected to grow at an 8.7% compound annual rate through to 2030.

With an estimated 76 million dogs and 60 million cats in US households, demand for advanced veterinary care continues to increase—particularly for complex conditions such as cancer.

InSpecta is designed to address this need by providing real-time, non-invasive imaging across a broad range of animal applications, positioning Optiscan to participate in this expanding market.

Complex Lodgement Process

“Creating and lodging a dossier is not a simple process—this detailed document unambiguously demonstrates the ability to translate our complex imaging technology into a format suitable for regulatory review, a critical step in the journey toward clinical adoption,” chief executive officer Dr Camile Farah said.

“Importantly, the frameworks and capabilities developed through this process are expected to support and accelerate future submissions across our portfolio.”

Optiscan sees two separate opportunities in the US market.

“As well as the commercial opportunity offered by this market segment, it will also showcase the real work impact our technology can have in the treatment of animals.”

“By introducing real-time, non-invasive imaging across the full spectrum of veterinary services, InSpecta has the potential to fill a critical gap and help transform the way millions of companion animals are treated.”