Why Tampere health tech companies now look to the USA before the EU

Health technology companies in the Tampere region have received market clearances from the U.S. Food and Drug Administration (FDA) during the past winter. According to one CEO, the order of market entry has reversed over the past decade. Previously, companies typically sought an EU CE mark before expanding across the Atlantic.

Text: Petri Kangas / Business Tampere

Health technology companies in the Tampere region have received FDA clearances to enter the U.S. market during the past winter.

The approvals were granted through the FDA’s 510(k) process, in which the agency determines that a medical device is as safe and effective as a comparable product already on the market. In mid-February, Tampere-based Biomendex received clearance for its bone substitute technology.

A few months earlier in November, neighboring companies at the Kauppi health and research campus in Tampere, Inion and Neuro Event Labs, also received FDA clearance. Inion has obtained FDA approvals before, while Biomendex and Neuro Event Labs are first-timers.

Inion manufactures bioabsorbable surgical implants such as screws, plates and pins used, for example, in treating bone fractures and other orthopedic procedures.

Neuro Event Labs’ Nelli system is used in hospitals to monitor epilepsy patients using video and audio and automatically detect potential seizures.

An eighteen-month process

“This is the first FDA clearance for our product for human use, so it is a major milestone for us,” says Biomendex CEO Pasi Kankaanpää.

Kankaanpää recalls that the preparatory work with the FDA began in December 2024.

“The actual testing was carried out during 2025. We received the final results toward the end of the summer and submitted our application to the FDA in late autumn. After the submission, the agency sent several rounds of questions. We responded around Christmas and again early this year. In February we finally received the letter confirming that the application had been cleared,” Kankaanpää says.

In spring 2025 we previously reported on Biomendex’s interest in expanding to the U.S. market.

Ten years ago, almost every health technology company would first obtain the CE mark in Europe and only then expand to the United States. In many cases, the situation has now reversed.
Pasi Kankaanpää, Biomendex

The model has changed

Despite geopolitical uncertainties this spring, the U.S. market continues to attract companies from the Tampere region.

“The United States is simply a massive market. Roughly two thirds of the global bone substitute market is located there. For a startup like ours, the FDA pathway has in many cases become more straightforward than obtaining the European CE mark. Ten years ago it was the opposite. Back then almost everyone wanted the CE mark first and only then moved to the U.S.,” Kankaanpää says.

Receiving the first FDA clearance provides important validation for a young company. Access to capital is another key factor for startups, and according to Kankaanpää, venture capital markets in the United States are significantly larger than in Europe.

“An FDA decision is a strong validation. When the agency and partners such as the Mayo Clinic have evaluated the technology, discussions with investors become much easier. The focus now shifts to commercialization: how we build distribution and partnerships in the U.S. market. We already have a subsidiary in the United States. It is not yet operational, but once commercial activities begin, people will likely be hired there to coordinate sales and partnerships,” Kankaanpää says.

In the future, obtaining additional FDA clearances may become easier for Biomendex, Kankaanpää estimates. New applications can be compared to the company’s already approved product.

Key health tech states

Kankaanpää highlights the U.S. East Coast, Minnesota, home to the Mayo Clinic, as well as California and Texas as key regions for the health technology sector. Finland opened a Consulate General in Houston, Texas in July 2025.

Timo Hänninen, account manager for health companies at Business Tampere, welcomes the recent FDA news.

“It is great to see companies from the Tampere region reach the world’s largest market and successfully pass the FDA 510(k) process. The United States is an attractive market in many ways,” Hänninen says.

Hänninen agrees on the importance of the key states and notes that Business Tampere can support companies even after FDA clearance.

“In March we will lead an export promotion and networking mission to Texas in the United States. The goal is to help Finnish health and technology companies start or scale their business in the U.S. market. After FDA clearance, the next step is building distribution channels and partnerships that bring products to hospitals,” Hänninen says.