Category: Clearances

Clearances

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FDA Clears Boston Scientific Insertable Cardiac Monitor

Boston Scientific has received 510(k) clearance from the U.S. FDA for the LUX-Dx Insertable Cardiac Monitor System, a device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke, and syncope.

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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 Awards Grants to Advance Pediatric Medical Device Development

The U.S. FDA announced that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia across the country that will provide advice and support services to innovators of children’s medical devices. The program aims to enhance the development, production, and distribution of pediatric medical devices and has awarded $37 million to various consortia since 2009.

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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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