RetinaLogik has secured Class II medical device approval from Health Canada for its visual field exam platform.
Coming in the form of a wearable virtual reality (VR) headset, which guides patients through a range of vision tests, the company’s platform is ISO-13485 and MDSAP certified and has been registered with the US Food and Drug Administration (FDA).
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Upon exam completion, AI algorithms incorporated into the platform analyse the results, assisting clinicians in identifying patterns of deterioration or improvement to help guide treatment decisions and monitor the effectiveness of interventions in eye conditions such as glaucoma.
Coinciding with the Health Canada approval, RetinaLogic has completed a C$1.1m fund raise, bringing its funding to date to around C$2m since the company’s launch in 2021.
With plans to expand the adoption of its platform across North America and beyond, RetinaLogik CEO Dr Abdullah Sarhan called the milestones a “proud moment” for the company.
“With the support of our investors and partners, we’re excited to continue growing and improving the future of eye care for everyone,” said Sarhan.
The round was co-led by Spring Impact Capital and the University of Calgary’s investment fund, UCeed, and included participation from existing backers Startup TNT and HaloHealth.
In obtaining device approval from Health Canada, RetinaLogik received support from the Accelerating Innovations into Care (AICE) programme of Alberta Innovates, an initiative of the province’s government founded to support early-stage startups across a range of disciplines.
Alberta Innovates’ health vice president Trevor Lynn commented: “This accomplishment is an example of Alberta’s success commercialising health innovation to improve the patient experience and enable easier patient care access in the community.”
In other eye care news, Perfuse released Phase I/IIa data earlier this month indicating that its PER-001 intravitreal implant for glaucoma was well-tolerated, with only a single, mild, and transient drug-related adverse event of vitreous floater reported.
Last year, Sight Sciences’ OMNI surgical system to reduce intraocular pressure in patients with primary open-angle glaucoma received FDA clearance while ViaLase gained a European CE mark for a femtosecond laser for glaucoma treatment.
