Develops and manufactures brain monitoring systems for measuring cerebral oxygen saturation and cerebral blood flow
Luciole Medical AG
Zurich (CH) · Hamburg (DE)New on Amplifa
About Luciole Medical
Luciole Medical AG, based in Zurich, develops and manufactures systems for monitoring brain functions. The portfolio comprises an adhesive measurement patch, an intracranial probe, and an end-to-end analytics platform with proprietary software for capturing cerebral oxygenation and blood flow in real time. The technology is based on near-infrared spectroscopy: four laser wavelengths and a patented algorithm separate oxygen saturation signals from two different measurement depths in the brain. The systems are used in anesthesiology (cardiac surgery, orthopedic/spinal surgery, ECMO), neurointensive care, pediatrics, and sleep apnea diagnostics. In 2023, Luciole Medical acquired Spiegelberg GmbH & Co. KG in Hamburg, a provider of specialized devices and consumables for neurosurgery whose sales span more than sixty countries. Production and final inspection of the medical devices take place in Zurich; the company is privately financed.
- Site
- Zurich
- Processes
- Development and production of brain monitoring systems (adhesive patch, intracranial probe), End-to-end analytics platform with proprietary software, Development of a wearable brain monitoring device, Combined manufacturing and sales channels with Spiegelberg
- Materials
- Near-infrared spectroscopy (NIRS), Adhesive brain monitoring patch, Intracranial probe
- Certificates
- EN ISO 13485:2016, MDR – EU 2017/745, Annex IX, Chapters I and III (QMS), MDR – EU 2017/745, Annex IX, Chapter II (Technical Documentation Assessment), MDR – EU 2017/745 (QMS, Annex IX Chapters I and III), MDR – EU 2017/745 (Technical Documentation, Annex IX Chapter II)
- Industries
- Medical technology / Neuromonitoring, Anesthesiology, Neurointensive care, Pediatrics, Sleep apnea diagnostics, Medical wearables
- 01
Development (design)
- 02
Production
- 03
Final product inspection and testing
- 04
Analytics platform/software
- 05
Sales
Technology and Processes
Near-infrared spectroscopy (NIRS)
Measurement of brain tissue oxygen saturation via the absorption of near-infrared light by hemoglobin.
Adhesive brain monitoring patch
Non-invasive measurement of cerebral oxygenation outside the skull.
Intracranial probe
Invasive measurement of intracranial pressure, blood flow, and oxygenation in brain tissue.
Locations
Zurich
CHHeadquarters, design, production, and final product inspection
Hamburg
DESpiegelberg GmbH & Co. KG – development, production, and sales (subsidiary since 2023)
Products
Inside the production
Industries
Additional services
Quality and Certification
Luciole Medical is certified to EN ISO 13485:2016 and holds MDR certifications (EU 2017/745) from the notified body DNV MEDCERT; design, production, and final product inspection take place in Zurich.
| Evidence | Zurich |
|---|---|
| EN ISO 13485:2016 | |
| MDR – EU 2017/745 (QMS, Annex IX Chapters I and III) | |
| MDR – EU 2017/745 (Technical Documentation, Annex IX Chapter II) |
History
- 2023
Acquisition of Spiegelberg GmbH & Co. KG (Hamburg), a provider of specialized devices and consumables for neurosurgery
- 2024
Receipt of MDR certification (EU 2017/745) from DNV as of 26.03.2024