Novigenix SA reported interim European validation data for its whole blood RNA signature for early detection of precancerous colorectal lesions. The data was presented in early July at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona.
Five long years after the publication of the now-notorious Katsanos paper, the U.S. FDA has issued a final determination about whether devices indicated for treatment of peripheral artery disease carry the threat of excess mortality when using paclitaxel as an antiproliferative.
Cymedica Orthopedics Inc. is relaunching its wearable knee pain relief treatment under the Motive Health Inc. brand, following U.S. FDA clearance for direct-to-consumer (DTC) use. The muscle stimulating Motive Knee band is now available without a prescription for anyone suffering from knee pain.
Coloplast A/S agreed to acquire wound care company Kerecis Ehf for up to $1.3 billion in a bid to strengthen its presence in the high-growth, U.S.-centric biologics segment. Kerecis has developed a technology which uses intact fish skin from Atlantic cod to treat chronic wounds. It has around 5% share of the U.S. biologics market.
U.S. FDA clearance of Mobi pumped up Tandem Diabetes Care Inc. on Tuesday. The miniaturized insulin pump is indicated for individuals with diabetes, aged 6 years and up, with the FDA action boosting Tandem’s share price from $26.41 to $29.20 in morning trading before falling back to $27.12 by the end of the day.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Changzhou Biowin, Getinge, Motive Health, Shineco.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Broncus, Coloplast, Kerecis, Koru Medical, Owlet, Pentax Medical, Sequana Medical.
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