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Curated updates on export/import regulations, technology controls, dual-use items, and compliance alerts relevant to European tech entering North American markets. The list is updated from RSS feeds; each item links to the original source.
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Inference is moving permanently off the cloud. Here is where edge AI lands first at scale, what it means for product architecture, and which applications beyond defense are worth paying attention to.
Oura raised $900M at an $11B valuation. The investor narrative is that consumer wearable data is the foundation for medical-grade AI. There are three problems with that thesis — and they compound.
Explainability is now the gating condition for staying outside FDA device regulation. EU MDR/IVDR companies have a structural advantage — if they use it correctly.
FDA's 2026 guidance exempts wellness-category wearables from premarket review. For European health tech companies under MDR/IVDR, this creates both commercial pressure and a strategic opening.
FCC is just the start. European tech companies entering North America face ISED, FDA, FAA, PTCRB, carrier approvals, and dual-use export controls. Here's how to navigate without costly surprises.
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The Media Bureau enters into a consent decree with SDK Franco, LLC.
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OET clarifies that waiver of sections 2.803(b) and 2.1204(a) of the Commission's rules is not required for D-Fend to import and market its C-UAS equipment to SLTT law enforcement agencies trained and certified under the SAFER SKIES Act.
Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.
Listing of Medical Device 2024 Safety Communications
If the hand controls to adjust the bed are not locked, children could adjust the bed and become entrapped.
EC-TRADE/2026/OP/0021-PIN - Procurement of data for Access2Markets for 2027-2030
Sources include BIS, EU Commission Trade, Global Affairs Canada, FCC, FDA, PTCRB, Federal Register, and internal Norseman alerts.