FDA news, regulatory

OSSIO Inc.’s OSSIOfiber compression screw portfolio received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts of the upper extremity, fibula, knee, ankle, and foot in the presence of appropriate brace and/or immobilization. This is the third FDA clearance for the company’s OSSIOfiber Intelligent Bone Regeneration Technology that uses bio-integrative material to provide stability and secure bone fixation while leaving no permanent hardware behind.

OSSIO’s Compression Screw Portfolio will initially be comprised of a 4mm dia. cannulated, headless, partially threaded compression screw in 26mm to 60mm lengths. The portfolio will expand to include 3.5mm to 6.5mm diameters with varying lenghts and geometries.

Laboratory blood glucose reference analyzer

The Nova Primary, a rapid, accurate, easy to use, blood glucose laboratory analyzer from Nova Biomedical replaces the discontinued YSI STAT PLUS 2300 Glucose and L-Lactate reference analyzer.

Available for sale in CE-regulated countries, the Nova Primary was also submitted to the FDA for 510(k) clearance in November 2020 and is anticipated to receive clearance in the first half of 2021.

Similar to the YSI 2300, Nova Primary uses a single, reusable glucose electrochemical sensor based on glucose oxidase and has a measurement range of 10 mg/dL to 900mg/dL. In clinical laboratory studies using venous whole blood and plasma, it demonstrated excellent correlation to the YSI 2300 and traceability to NIST glucose standards.