Category: Clearances



FDA Clears Pentax Medical Endoscopy System

Montvale, N.J.-based Pentax Medical has received FDA 510(k) clearance for the Imagina Endoscopy System, an endoscopy platform for gastrointestinal (GI) procedures. Specifically, Imagina offers practitioners a platform to visualize anatomy and improve the operator experience.



VoCare Debuts Mobile Multi-Diagnostic Device

Indiana-based VoCare, Inc. has developed a professional-grade medical diagnostic device that collects six different health vitals and is equipped with WiFi, Bluetooth, and 4G LTE for data transmission, without the need for separate peripherals or an external hub.

FDA OKs EKF Diagnostics’ POC Hemoglobin Analyzer

UK-based in vitro diagnostics company EKF Diagnostics announces that the U.S. FDA has granted it 510(k) clearance for its hand-held, reagent-free hemoglobin analyzer, the DiaSpect Tm. The device is cleared for use in point of care and Certificate of Waiver settings, such as physicians’ offices, clinics, and other non-traditional laboratory locations.

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