How Lazurite Scored Rapid FDA Approval for Their Wireless Surgical Camera

In health innovation, sometimes the eureka moment that sparks a business is subtle. Maybe you’re a physician clicking away on an electronic health record and it dawns on you that you could do the same thing with fewer clicks. An idea is born.

At other times, inspiration smacks you in the face. Or, as in the case of Eugene Malinskiy, the CEO & Co-founder of Lazurite (a StartUp Health company since 2017), smacks someone else. In this podcast, we’ll hear how a fateful day in the operating room set Malinskiy on a multi-year journey of creating the world’s first wireless minimally invasive camera system for use in the OR. The big challenge, as he’ll explain, was getting a powerful enough light system into the unit. This month, Malinskiy and his team celebrated the milestone of receiving FDA clearance for their ArthroFree camera, so we caught up with them to hear the latest.

We also hit Malinskiy up for some practical advice on navigating the FDA process. One tip? Find and invest in an experienced regulatory partner early in the process.

Learn more and connect with the team at Lazurite.

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