Milestones

    • Acquisition of Bemes' Sales Division in the US and Inauguration of our Sales Subsidary in North America (St. Louis)

       

    • 510K Approval for the SenTec OxiVenTTM System
    • More than 120 clinical studies
    • Release of the revolutionary OxiVenT™ Sensor for combined tcPCO2, tcPO2, SpO2 and Pulse Rate Monitoring along with SDM software SMB V8.00 /MPB V6.00 and V-STATS 4.00 (CE approval obtained in May 2014, 510K approval obtained in December 2015)
    • Product change V-Sign Sensor 2 (VS-A/P/N): advanced coating of the sensor cable in order to improve chemical resistance during cleaning and disinfection. 
    • New disposable: Staysite™ Adhesive, model SA-MAR, optional adhesive film for better skin attachment. To be used (optionally) together with SenTec’s Multi-Site Attachment rings, models MAR-MI and MAR-SF, in certain clinical settings in order improve adhesion e.g. under challenging motion condition.
    • Software Releases: SMB 7.02, MPB 5.02, V-STATS 3.01.1 (followed by version 3.02) e.g. featuring Russian language on the monitor software
    • Release of an expanded/improved
      • firmware of the SenTec Digital Monitor (SMB V07.01/ MPBV05.01) introducing (among other features) the possibility to store up to 4 user profiles, a V-CheckTM Mode, baseline and event markers, additional measurement screens with delta-10 and delta-B values, as well as the possibility to customize the Severinghaus correction (password protected)
      • version of V-STATSTM (version 3.01) intoducing (among other features) the possibility to customize the report, print and store PDF reports, the possibility to split a measurement into multiple analysis periods (e.g. for split-night-analysis), operator events, several profiles for the SenTec Digital Monitor preconfigured by SenTec and tailored to optimally fit the specific needs of different clinical settings.
    • More than 90 clinical studies available that are related to the SenTec Digital Monitoring System (SDMS)
    • Regulatory approval of the new SDMS configuration in Canada
    • Market release and regulatory approval in Europe, Japan and USA of the new SDMS configuration comprising
    • Expansion of the SDMS’ intended use to include SpO2/PR monitoring at the forehead and cheek of adult/pediatric patients (with V-Sign™ Sensor 2) and at the finger, toe of patients weighing > 20 kg (with SpO2 Soft Sensor)
    • Introduction of reloadable V-Sign™ Membrane Changers
    • SenTec products being distributed on all continents and in more than 40 countries.
    • More than 75 clinical studies available that are related to the SDMS
    • Regulatory approval of the SDMS in Canada
    • Release of an expanded/improved firmware of the SenTec Digital Monitor (SMB V06.21.x / MPB V04.04.x) introducing (among other features) on screen viewing and printing of trend data and statistical summary
    • SenTec products being distributed in more than 30 countries
    • SDMS expansion to include the Multi-Site Attachment Rings and, concurrently, expansion of its intended use to include tcPCO2-only monitoring in neonatal and adult/pediatric patients with the V-Sign™ Sensor VS-A/P being applied to conventional tcPCO2 monitoring sites
    • Regulatory approval of the SDMS in Taiwan (tcPCO2, SpO2, and PR monitoring at the ear lobe of adult and pediatric patients).
    • SenTec Digital Sensor Technology Expanded into Schiller Patient Monitoring Devices.
    • SDMS expansion to include V-STATS™ (Europe only).
    • Market release of the SDMS in the United States and Japan
    • Market release of the SDMS in Europe and South Korea
    • Regulatory approvals of the SDMS in South Korea, USA (FDA, 510k) and Japan (tcPCO2, SpO2, and PR monitoring at the ear lobe of adult and pediatric)
    • CE approval (CE mark) of the SDMS for tcPCO2, SpO2, and PR monitoring at the ear lobe of adult and pediatric patients. At that time the SDMS consisted of the SenTec Digital Monitor, the V-Sign™ Sensor VS-A/P, the Digital Sensor Adapter Cable, the Ear Clip, the Service Gas, the Contact Gel, and the V-Sign™ Membrane Changer
    • Production facilities built up

    ISO 9001 and ISO 13485 certification

    Foundation of SenTec AG