Dermasensor Inc. received U.S. FDA clearance for its non-invasive skin cancer evaluation device that provides quantitative identification of all skin cancer types at the point of care and within seconds. The point-and-click device is designed to facilitate detection of skin cancers by primary care physicians (PCPs) and speed the time to diagnosis and treatment.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robitica, B-rayz, Imvara, Reflow Medical.
Researchers from Indiana University are seeking patent protection for an electromagnetic field (EMF) generation system for treating neurodegenerative diseases. The EMF generation system emulates a small-scale magnetic resonance imaging (MRI) machine, producing the same 64 MHz frequency at a much lower operating power.
The U.S. FDA has announced a class I recall of Iveninx large-volume infusion pumps made by Fresenius Kabi USA of Lake Zurich, Ill., due to a mechanical issue with fluid valve pins that could cause the pumps to shut down. Fresenius is rolling out a remediation plan for more than 900 pumps affected by the recall, which to date has been associated with no reports of injury or death.
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