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Mei Chen Spent Two Years on an FDA Filing for Soraya. Then the Rules Changed.

Mei Chen submitted Soraya's De Novo FDA filing in November 2024. Six months later, the regulatory environment shifted under her. The story of building women's health AI through the chaos of 2025-2026.

Mei Chen

Soraya

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Dmitri Werner Almost Built Autonomous Drones. He Built Edge AI Hardware Instead.

Fast TrackHardware

9 min read·Edge AI

Dmitri Werner Almost Built Autonomous Drones. He Built Edge AI Hardware Instead.

Dmitri Werner spent twenty months and 1.3M euros building autonomous delivery drones. Then a German factory operator told him what he actually needed — and Helix Edge was born.

Dmitri WernerHelix Edge

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The real storiesbehind the build.

Mei Chen Spent Two Years on an FDA Filing for Soraya. Then the Rules Changed.

Every story, unfiltered.

Dmitri Werner Almost Built Autonomous Drones. He Built Edge AI Hardware Instead.

Built something worth telling?

The real stories
behind the build.