We’re proud to share that Genalyte has officially submitted the Merlin fully-automated laboratory to the FDA for premarket clearance, covering a menu of 39 analytes, with more to come!
This marks a major step forward in our mission to bring real-time diagnostics to the point of care — and it's the result of incredible collaboration across our clinical, regulatory, engineering, and operations teams.
A heartfelt thank you to everyone who poured their energy, expertise, and late nights into making this submission possible. We couldn't be more excited about what's ahead for the company and patients.
Onward! 🚀