Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy. Read More
Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution. Read More
Toku Inc. recently obtained CE and UKCA marks for its artificial intelligence (AI) technology, Clair, which evaluates the risk of cardiovascular disease (CVD) using retinal images captured during an eye exam. Read More
COVID-19 severity remains open to several questions. Researchers at the University of California Los Angeles (UCLA) have revealed how SARS-CoV-2 causes acute inflammation instead of the symptoms of a common cold. This effect could be initiated by the peptide fragments of the coronavirus released when the host eliminates the virus, which can form pro-inflammatory complexes that trigger an amplified immune response. Read More
The Belgian academic Stefan De Wachter is seeking patent protection for methods of ensuring pelvic health and treating a disease or disorder characterized by a dysfunctional autonomic nervous system using neuromodulation and applying a burst stimulation pattern of electric pulses of high frequencies from electrodes located in the proximity of the sacral plexus and/or pelvic plexus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerin, Appliedvr, Kernel, Cleerly, Medrhythms, MIVI Neuroscience. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fresenius Medical Care, Sibel Health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuryn, Biotronik, Evaluate Diagnostics, Exactech, GE Healthcare, Hitachi, IMDS, Inspira Technologies, Lucid Diagnostics, Medquest, Obviohealth, Oracle, Potrero, Qiagen, Spectrum Science, Statera, Sysmex, Volta Labs. Read More
