The University of Southern California (USC) reported filing a patent for a retinal ganglion cell (RGC) stimulation system in which electrodes may be placed in, around or near sites of optic nerve injury to generate electric fields that can direct the direction of axonal regeneration.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon Therapies, Curio Digital Therapeutics, Endotronix, Whiteswell.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axxess, Brainomix, Contego, Circadian, Nanoflex, Picard Medical, Revbio, Rhaos, Statlab, Sulos, Waldemar Knittel.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endotronix, Foundation Medicine, Histosonics, Hyperfine
.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abacam, Chromacode, Danaher, Foxo, Neway, Quest.
The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances. An example of this is the September 2023 guidance for antimicrobial susceptibility test (AST) system for breakpoints in device labeling, a document that represents a jarring update to the legacy version published in 2009.
Dexcom Inc. revealed new clinical data at the European Association for the Study of Diabetes (EASD) which highlighted the benefits of the use of continuous glucose monitoring (CGM). Results from the COMISAIR seven-year study, the longest prospective real-world CGM trial ever conducted, showed significant and continued reduction of HbA1c with the use of real-time CGM by people with type 1 diabetes.
RSS
