Paris‑based En Carta Diagnostics received Breakthrough Device designation from the FDA for EC Pocket Lyme, a point‑of‑care molecular test that detects Borrelia directly from skin interstitial fluid using a microneedle sampler and loop‑mediated isothermal amplification. The single‑use cassette employs aptamer‑based capture chemistry and is designed for rapid, decentralized testing at the tick‑bite site. En Carta said the designation will enable closer collaboration with the FDA and accelerate the regulatory pathway. The platform’s programmable molecular signatures could be repurposed for diverse infectious and veterinary indications, positioning the company to build a broader diagnostics pipeline if clinical performance and manufacturing scale align with regulatory expectations.