Quibim SL recently launched its artificial intelligence (AI)-based software QP-Brain, which is designed to detect early-stage neurodegenerative diseases, after it received U.S. FDA 510(k) clearance, as well as CE and UKCA marks from the EU and U.K. regulators, respectively. QP-Brain quantifies and presents data from patients’ brain images to help clinicians with early diagnosis and treatment strategies for diseases such as Alzheimer’s, multiple sclerosis and dementia.
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.