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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
The tension of clashing politics, policies and prescription drug pricing is coming to a head as U.S. Sen. Bernie Sanders (I-Vt.) acts on his threat to hold presidential appointments in the health arena hostage until President Joe Biden commits to do more to bring down drug prices. Read More
The U.S. FDA reported July 11 a class I recall for patient return electrodes used during electrosurgical procedures that may burn the patient with sufficient severity to induce a third-degree burn. More than 21,000 of the electrodes, made by Raritan, N.J.-based Ethicon Inc.’s Megadyne division, are subject to the recall, although the agency said the manufacturer is still conducting a root cause analysis of the issue. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accustem, Arkray, Coagusense, GI Dynamics, Hyperfine, Illumina, Labcorp, Medgenome, Morphic Medical, Nanostring Technologies, Owlet, Pixium, Radon Medical, Tristate Biomedical, Rockwell Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accurkardia, Spark Biomedical, Tandem Diabetes Care. Read More
