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    FDA clears shock absorbing knee implant for osteoarthritis not advanced enough for arthroplasty

    FDA clears shock absorbing knee implant for osteoarthritis not advanced enough for arthroplasty

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    The US Food and Drug Administration has authorized marketing of MISHA Knee System a breakthrough technology of shock absorbing knee implant for osteoarthritis not advanced enough for arthroplasty. The implant placed alongside the knee joint  helps reduce the amount of load carried by part of the joint. Unlike conventional knee replacement, the knee joint is […] More

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    FDA withdraws preterm birth drug Makena (hydroxyprogesterone) and its generic versions

    FDA withdraws preterm birth drug Makena (hydroxyprogesterone) and its generic versions

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    USA: Noting that the drug was ineffective in treating the complication of preterm birth, the US Food and Drug Administration (FDA), in its recent announcement, has decided to withdraw approval of Makena, hydroxyprogesterone caproate injection, and its generic versions. The decision was issued jointly by the FDA Commissioner and Chief Scientist. FDA stated, “Effective from […] More

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    FDA approves RemeOs trauma screw as first bioresorbable metal implant for marketing

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    The Food and Drug Administration has granted market authorization to Bioretec for its RemeOs trauma screw which is designed to aid fixation for patients with ankle fractures. The benefits of the RemeOs trauma screw have been validated in clinical trials and have already previously been recognized by the FDA granting the Breakthrough Device Designation. Bioresorbable […] More