Management teams beset by angry activist investors may take some solace in Ernst & Young (EY)’s latest Pulse of the Industry report, which confirms what med-tech executives have said for the better part of two years. A post-COVID-19 slump combined with inflation and other unfavorable capital conditions have slammed the global med-tech industry back to earth with little likelihood of a return to the halcyon days of 2021 any time soon.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.
Inbrain Neuroelectronics SL was granted a breakthrough device designation from the U.S. FDA for its graphene-based neural platform as an adjunctive therapy for treating Parkinson’s disease. The platform, called intelligent network modulation system, harnesses the power of graphene and artificial intelligence to deliver highly focused, adaptive neuroelectronic therapy that re-balances pathological neural networks, easing the symptoms of Parkinson’s.
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
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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.
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