Dutch start-up rapidly wins FDA approval

inMotion VR was one of the first European VR healthcare solutions to receive registration from the U.S. Food and Drug Administration (FDA).

Registration as a medical device for Corpus VR provides the company with significant opportunities. It allows them to work with hospitals, clinics and other healthcare facilities in the US. Moreover, it opens the doors to collaboration with US researchers and companies, which can lead to further development and innovation in the field of VR in healthcare. And certainly also in the prevention and home rehabilitation market.

Almost impossible

The startup was one of last year's finalists for the National Care Innovation Award with Corpus VR, which turns rehabilitation into a game with VR glasses. CEO Gert-Jan Brok: "We were dreading the application like a mountain. We heard from everyone that it would be almost impossible to get FDA approval. So we approached various parties in the Netherlands and the US. They all asked for enormous amounts of money. And that while the application itself already costs 10,000 euros."

Giant mountain of forms

Brok unexpectedly ran into a consultant with extensive knowledge and experience in this area who was willing to try for a much lower fee. "The mountain of forms is huge, but he knew exactly what we had to fill out a submit and what we didn't have to. We spent two weeks on it and after waiting 2.5 months we heard it was all done."

Reimbursement system

Brok went to the CES in Las Vegas with Health Holland back in 2018. "There we did plenty of networking and we did see opportunities there, but we still focused on Europe first. Of course, European regulations were also an obstacle. Now that we have taken them, we notice that the Dutch and European markets are limited. Of course you run into the fact that so many different languages are spoken. Moreover, the reimbursement system is different everywhere."

Giant market

"The market in the US is huge. We have to be able to manage it all as a small company, which is why we hired an agent who will sell the product for us."

Who the helpful advisor was, Gert-Jan Brok is not yet willing to say. What he does say is that other companies should not be put off by the complicated procedure. "What we can do, others can also do."

Managing