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
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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The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances.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.
Easymotionskin Tec AG is seeking patent protection for a wearable product that delivers transcutaneous electromyostimulation (EMS) of pelvic floor musculature through the body’s perineum, for the non-invasive treatment of incontinence, particularly stress incontinence. The invention is said to be suited to nearly all patients, including those patients who cannot insert anal or vaginal probes that provide pelvic floor training by EMS.
Unlocking the future of drug development often means removing obstacles that currently stand in the way. Reimbursement is one of those obstacles, as is keeping humans deeply involved as innovators and patients even as artificial intelligence (AI) increases its role. A panel of developers spoke about what they anticipate will be the biggest changes in the coming 10 to 20 years at the BioFuture 2023 conference in New York on Oct. 5. A common theme was reforming the structure of reimbursements, which has traditionally been a problem in the digital therapeutic realm, according to Eric Elenko, chief innovation and strategy officer at Puretech Health plc.
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