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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

CE mark

UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test

MedDevice Startups Staff · Sep 16 · 2 min read · Via UpFront Diagnostics announcement

UpFront Diagnostics said on September 16 that LVOne carries a CE mark. The company calls it the first blood-based in vitro diagnostic certified in Europe to diagnose stroke.

The test measures GFAP and D-dimer together and returns a result in about 10 minutes. Validation ran with more than 500 patients across six NHS stroke hospitals, in partnership with Newcastle University. The reader is portable and the reagents sit at room temperature, so a paramedic can run it in the back of an ambulance.

UpFront Diagnostics was founded in Cambridge in 2017. It already holds a UKCA mark, runs a pilot with London Ambulance Service, and carries ISO 13485:2016 for design, development and manufacturing. CEO Gonzalo Ladreda and chief scientific officer Edoardo Gaude lead the company.

Certification was the easier half of this problem. Routing a patient past the nearest hospital to a thrombectomy center takes ambulance protocol changes and a payer willing to fund the test, and a CE mark buys neither.

Questions & Answers

What is the UpFront Diagnostics LVOne test?

LVOne is a rapid blood test from UpFront Diagnostics that identifies large vessel occlusion stroke. It measures GFAP and D-dimer and returns a result in about 10 minutes on a portable reader.

When did UpFront Diagnostics get the LVOne CE mark?

UpFront Diagnostics announced the CE mark on September 16, 2026. The company says LVOne is the first blood-based in vitro diagnostic certified in Europe to diagnose stroke.

What clinical validation supports LVOne?

UpFront Diagnostics validated LVOne with more than 500 patients across six NHS stroke hospitals, working with Newcastle University. The test is also UKCA marked and is in pilot use with London Ambulance Service.

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